Events

Retiro De Equipo (Recall) de Mectronic UCLIP V100D

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Cardiovascular Revascularization & Surgical Therap.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    55900
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2030-2010
  • Fecha de inicio del evento
    2010-04-02
  • Fecha de publicación del evento
    2010-07-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92203
  • Notas / Alertas
    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
    clip, implantable - Product Code FZP
  • Causa
    Medtronic received reports involving the v100d u-clip where during handling, the release mechanism has become separated from the needle assembly. these instances of separation have occurred when pulling the clip through prosthetic material, or when grasping and releasing the clip using robotic instrumentation. while this issue does not impact performance of the clip once implanted, separation of.
  • Acción
    The firm, Medtronic CardioVascular, sent an "Urgent Medical Device Recall Notice", dated April 2, 2010, to Risk Managers of each affected account. The letter described the issue, identified affected product, and the action to be taken by customers. The customers were ask to immediately discontinue use of affected devices and to quarantine all unused V100D U-Clip inventory. The letter stated that a Medtronic representative will contact the account to arrange return of the V100D U-Clips devices and that credit will be issued upon return of unused devices. Medtronic has stopped manufacture of the product therefore replacements will not be available. Devices can be returned to Medtronic CardioVascular, 7611 Northland Drive, Brooklyn Park, MN 55428. The customers were ask to please fill out the Medtronic Recall Certificate and fax it to 651-367-2620. If you need additional information, please contact CardioVascular LifeLine Technical Services at 877-526-7890, or you local Medtronic sales representative.

Device

Mectronic UCLIP V100D
  • Modelo / Serial
    Lot numbers: 0509537, 0509640, 509755, 0510102, 0511801, 0512206, 0512406, 0512528, 0516564, 0516805, 0517446, 0517447, 0518048, 0518149, 0518643, 0518701, 0519441, 0519442, 0519552, 0519553, 0520004, 0520005, 0520218, 0520219, 0520929, 0520930, 0523108, 0523109, 0523529, 0523629, 0525614, 0525615, 0525722, 0526317, 0526330, 0526518, 0526519, 0527001, 0529801, 0529802, 0529914, 0530028, 0530029, 0530101, 0530102, 0530103, 0530104, 0530105, 0530602, 0530707, 0530802, 0532125, 0532126, 0532127, 0532128, 0532630, 0532719, 0532735, 0532829, 0532904, 0532905, 0532907, 0533301, 0533335, 0533401, 0533421, 0533509, 0533537, 0533538, 0534017, 0534123, 0534124, 0534125, 0534126, 0534201, 0600501, 0600502, 0600931, 0600932, 0601119, 0601120, 0601333, 0601334, 0601601, 0601602, 0601703, 0602303, 0602304, 0603017, 0603018, 0603105, 0603205, 0603206, 0603207, 0604414, 0604415, 0605106, 0605107, 0605403, 0606601, 0607201, 0607202, 0607903, 0607904, 0608607, 0614210, 0623313, 0623606, 0623607, 0625412, 0625708, 0626201, 0626202, 0626203, 6036442, 6036670, 6109808, 6109921, 6109955, 6110083, 6138406, 6185510, 6197801, 6197828, 7004186, 7132081, 7146061, 7147793, 7147806, 7352981, 7451269, 7460608, 7479974, 7589735, 7639747, 7661223, 7681451, 7972937, 7979266, 8189696, 8277354, 8289638, 8306418, 8393857, 8521396, 8591790, 8629823, 8646480, 8675184, 8792196, 8898855, 9018451, 9036333, 9145329, 9156757, 9264475, 9323332, 9343587, 9381161, 9498440, 9498589, 9522139, 9569658, 9569711, 9598408, 9602041, 9603836, 9632400, 9685157, 9693616, 9695953, 9695961, 9695988, 9739629, 9739670, 9769262, 9779938, 9790387, 9790395, 9806955, 9806964, 9806969, 9806972, 9806974, 9807053, 9822530, 9855639, 9856396, 9861501, 9866062, 9867454, 9868936, 9872244, 9872246, 9879754, 9879755, 9880630, 9885376, 9886127, 9886150, 9889117, 9889118, 9896073, 9896079, 9898916, 9899409, 9905053, 9914662, 9914664, 9951987, 9953209, 9954653, 9955080, 9962340, 9964925, 9964932, 9964933, 9972391, 9972392, 9975062, 9979217, 9983473, 10002996, 10003686, 10014769, 10017111, 10026931, 10031165, 10032632, 10034838, 10036286, 10036287, 10044003, 10044004, 10044005, 10051493, 10053662, 10053663, 10053664, 10071125, 10071127, 10071130, 10076492, 10076493, 10076494, 10076495, 10087478, 10087479, 10087481, 10097088, 10097089, 10097090, 10103752, 10103753, 10112428, 10112429, 10112431, 10112432, 10120939, 10135522, 10135524, 10135526, 10135529, 10197760, 10197768, 10197776, 10197781, 10282249, 10282251, 10282252, 10282254, 10282255, 10296725, 10296728, 10307473, 10307474, 10315453, 10315454, 10315455, 10315456, 10325134, 10325135, 10335048, 10347695, 10347696, 10347698, 10347700, 10365897, 10365898, 10372654, 10372656, 10375862, 10375863, 10398877, 10398878, 10398879, 10398880, 10407000, 10428853, 10444975, 10446876, 10469219, 10472750, 10472751, 10475205, 10480924, 10480926, 10480927, 10485845, 10485846, 10485847, 10488358, 10495393, 10495394, 10495398, 10497009, 10500586, 10519438, 10527121, 10535508, 10535509, 10537711, 10541287, 10541288, 10561651, 10561652, 10561653, 10561654, 10561656, 10582159, 10582161, 10582163, 10587526, 10590657, 10590658, 10590660, 10590661, 10656233, 10656234, 10656235, 10656236, 10665853, 10665854, 10665855, 10671984, 10671991, 10675076, 10686976, 10686977, 10686978, 10686979, 10691192, 10691195, 10711510, 10806542, 10806546, 10806551.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and countries of Australia, Belgium, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Japan, Korea, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Venezuela.
  • Descripción del producto
    Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools. || The Coalescent Surgical U-CLIP is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
  • Manufacturer
    Medtronic Cardiovascular Revascularization & Surgical Therap

Manufacturer

Medtronic Cardiovascular Revascularization & Surgical Therap
  • Dirección del fabricante
    Medtronic Cardiovascular Revascularization & Surgical Therap, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA