Medtronic Neuromodulation Medtronic Intrathecal Catheter, model 8731SC, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The 8731SC catheter is a two-piece catheter with a thin-walled spinal segment and a thicker-walled pump segment. These segments connect to each other with a connector pin. The pump segment connects to the pump with a sutureless pump connector. Contents: 38.1-cm spinal segment with length markings and guide wire 66-cm pump segment, separate connector p Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Intrathecal Catheter, model 8731SC, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The 8731SC catheter is a two-piece catheter with a thin-walled spinal segment and a thicker-walled pump segment. These segments connect to each other with a connector pin. The pump segment connects to the pump with a sutureless pump connector. Contents: 38.1-cm spinal segment with length markings and guide wire 66-cm pump segment, separate connector p
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
Model 8731SC used with all IsoMed Pump Models including 8472. Not lot or serial number specific.
Products Sold
Model 8731SC used with all IsoMed Pump Models including 8472. Not lot or serial number specific.
Medtronic Neuromodulation is recalling Medtronic Intrathecal Catheter, model 8731SC, Method of Sterilization: Ethylene Oxide. Medtronic, due to Current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (hereafter referred to as SC catheters) incorrectly states that S. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (hereafter referred to as SC catheters) incorrectly states that SC catheters are compatible with Medtronic IsoMed constant-flow infusion pumps. SC catheters are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. Medtronic has determined that SC catheters are not compatible with IsoMed pumps.
Recommended Action
Per FDA guidance
A "Medical Device Correction Notification" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants. A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card. Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, "Advisories".
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 noticeDistribution
As reported by FDA
WA, PR
Page updated: Jan 10, 2026