Device Recall Medtronic Intrathecal Catheter

Model 8731 Base Lot Numbers: B011311N, B011421N, B011422N, B011500N, B011721N, B011737N, B011738N, B011786N, N0012097, N0012140, N0012141, N0012521, N0012692, N0012814, N0012815, N0012816, N0013149, N0013150, N0013352, N0013353, N0013354, N0013355, N0013707, N0013710, N0013936, N0014007, N0014236, N0014237, N0014330, N0014331, N0014332, N0014722, N0015050.   *Model 8731 Catheters and Model 8598 Distal Revision kits have a Base Lot number of eight (8) characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number (the first eight characters of the product Lot No. found on the product labeling).

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom

Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.

Model 8598 Base Lot Numbers: B011468N, B011893N, B011894N, N0012129, N0012612, N0012969, N0012970, N0012971, N0014057, N0014058, N0014179, N0014180, N0016472.   *Model 8731 Catheters and model 8598 Distal Revision kits have a Base Lot number of eight (8) characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number (the first eight characters of the product Lot No. found on the product labeling).

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom

Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of the 8731 Intrathecal Catheter) . Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.

Product having a Use By Date prior to 25 Aug 2014

General Hospital and Personal Use Devices

3

Yes

Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.

Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. || The Medtronic Model 8596SC Pump Segment Revision Kit is used when a revision to the pump segment of the Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or Model 8731SC catheter. The catheter connects to the pump at the catheter port.

Product having a Use By Date prior to 25 Aug 2014

General Hospital and Personal Use Devices

3

Yes

Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.

Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package are STERILE. || The implantable Medtronic Model 8731SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731SC catheter. The catheter connects to the pump at the catheter port.

All SC Catheter Pump Revision Kits

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution: USA, Puerto Rico, Algeria, Aruba, Austria, Australia, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 66-cm pump segment with attached sutureless pump connector, spinal segment strain-relief sleeves (2), Pump segment strain-relief sleeves (2), Connector pin.