FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Model 8731SC Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
- Recall number
- Z-2174-2008
- Recalling firm
- Medtronic Neuromodulation
- Product
- Model 8731SC Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
- Status
- Terminated
- Initiated
- 2008-04-14
- Posted
- 2008-08-27
- Terminated
- 2008-09-10
- Reason
- The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.
- Root cause
- Device Design
- Action
- Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.
- Quantity
- 232 total from all models
- Distribution
- International Distribution --- country of Belgium.
- Lot, serial or model codes
- All lots numbers included
- 510(k) numbers
- not on file
- PMA numbers
- ["P860004"]
- Product code
- LKK
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28