Medtronic Neurological 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Medtronic Neurological
Lot Codes / Batch Numbers
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
Products Sold
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).
Medtronic Neurological is recalling Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pu due to Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit be. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.
Recommended Action
Per FDA guidance
An Urgent Worldwide Medical Device Recall letter was sent to affected customers 07/20/06 for delivery on 07/21/06. The letter describes the issue, identifies the affected product and list action required by the customer. Affected devices are to be removed from active inventory, quarantined and returned to Medtronic for a warranty credit. A Reply card is asked to be returned. Medtronic Representatives will follow-up by July 28, 2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026