FDA Device recall Z-1570-2014
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40
- FDA Device
- Class II
- terminated
- Published 2014-05-14
On 2014-05-14 the FDA classified a Class II recall of Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40 by Medtronic Neuromodulation, citing this recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1570-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-26 |
| Published | 2014-05-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
Reason
This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re
Identifiers
| code_info | This Medical Device Correction notification affects all SynchroMed II pumps. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1570-2014%22
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