FDA Device recall Z-0896-2018
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter
- FDA Device
- Class II
- ongoing
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter by Medtronic Neuromodulation, citing medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0896-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-08-09 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).
Reason
Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
Identifiers
| code_info | US: CFN #: GTIN: PIN: 8637-20 00643169508149 863702012H 8637-40 00643169508156…US: CFN #: GTIN: PIN: 8637-20 00643169508149 863702012H 8637-40 00643169508156 863704012H OUS: CFN#: GTIN : PIN: 8637-20 00643169700901 863700221K 8637-20 00643169700918 863700222K 8637-20 00643169700925 863700223K 8637-20 00643169700932 863700224K 8637-20 00643169700949 863700225K 8637-20 00643169700956 863700226K 8637-20 00643169700963 863700227K 8637-20 00643169700970 863700228K 8637-20 00643169700987 863700229K 8637-20 00643169700994 863700230K 8637-20 00643169732247 863700241K 8637-20 00643169732254 863700242K 8637-20 00643169732261 863700243K 8637-20 00643169732278 863700244K 8637-20 00643169732285 863700245K 8637-20 00643169732292 863700246K 8637-20 00643169732308 863700247K 8637-20 00643169732315 863700248K 8637-20 00643169732322 863700249K 8637-20 00643169732339 863700250K 8637-40 00643169701007 863700231K 8637-40 00643169701014 863700232K 8637-40 00643169701021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0896-2018%22
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