Drug recall
Medtronic SynchroMed II, Model 8637-20, Programmable pump
FDA recall event 93481 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 93481 |
|---|---|
| Recall numbers | Z-0614-2024, Z-0615-2024 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | Medtronic SynchroMed II, Model 8637-20, Programmable pump, Medtronic SynchroMed II, Model 8637-40, Programmable pump |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will… |
| Initiation date | Nov 13, 2023 |
| Report date | Jan 3, 2024 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 2182207 |
At a glance
- 1–9 Products in this recall
- 10–99 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: