Drug recall
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The…
FDA recall event 71047 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 71047 |
|---|---|
| Recall numbers | Z-1681-2015 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function. |
| Initiation date | Apr 10, 2015 |
| Report date | Jun 3, 2015 |
| Termination date | Nov 23, 2015 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3007566237 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: