U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, Catheter - Product Code DYB
Causa
St. jude medical received two complaints from customers involving the telesheath left atrial introducer system side arm detaching from the hub of the inner sheath. subsequent testing of telesheath inventory at st. jude medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.
Acción
100% of customers were notified by a personal visit by a St. Jude Medical representative, starting 8/4/2004. Letters were given by the representative to the consignee concerning the recall.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, Catheter - Product Code DYB
Causa
St. jude medical received two complaints from customers involving the telesheath left atrial introducer system side arm detaching from the hub of the inner sheath. subsequent testing of telesheath inventory at st. jude medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.
Acción
100% of customers were notified by a personal visit by a St. Jude Medical representative, starting 8/4/2004. Letters were given by the representative to the consignee concerning the recall.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, Catheter - Product Code DYB
Causa
A lot of product contains a 6f obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. the obturator is correctly sized (6f) per the labeling on both the sterile bag and shelf carton.
Acción
A letter dated 09/20/05 was sent to all customers explaining the issue and instructed customers that a St. Jude Medical Representative will facilitate in the product removel process. Full credit will be issued.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Vascular Closure Device - Product Code MGB
Causa
The angio seal vip 6f devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
Acción
All consignees were notified by letter on June 7, 2006. All product is to be retreived by recalling firm''s sales force for return to St. Jude Medical, in Minnetonka, MN.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
pacemaker - Product Code DXY
Causa
St. jude medical has identified a low-frequency anomaly in the software used in the aps iii model 3500/3510 and merlin pcs model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and elective replacement indicator (eri) status.
Acción
The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th.
In the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar.
In addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on St. Jude's website, www.sim.com
Completion of this advisory is estimated to be three months after its initiation.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
bradycardia and tachycardia device programmer - Product Code KRG
Causa
St. jude medical has identified a low-frequency anomaly in the software used in the aps iii model 3500/3510 and merlin pcs model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and elective replacement indicator (eri) status.
Acción
The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th.
In the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar.
In addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on St. Jude's website, www.sim.com
Completion of this advisory is estimated to be three months after its initiation.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
bradycardia and tachycardia device programmer - Product Code KRG
Causa
St. jude medical has identified a low-frequency anomaly in the software used in the aps iii model 3500/3510 and merlin pcs model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and elective replacement indicator (eri) status.
Acción
The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th.
In the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar.
In addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on St. Jude's website, www.sim.com
Completion of this advisory is estimated to be three months after its initiation.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Slittable CRT lead delivery tool - Product Code MCX
Causa
Device separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.
Acción
By Letter dated March 20, 2007, customers were requested to returned affected product immediately to St. Jude Medical. St. Judes Sales Representative will be assisting customers in retrieving the subject inventory from their shelves.
The firm instructed customers that if they should require further information regarding this issue, to contact the firm's Technical Service department at (800) 722-3774 or customers can contact local St. Jude Medical representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Causa
A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators
(icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Acción
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.