Drug recall
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed…
FDA recall event 81246 · Class II · Medtronic Inc.
Key facts
| Event ID | 81246 |
|---|---|
| Recall numbers | Z-0683-2019 |
| Recalling firm | Medtronic Inc. |
| Product type | Devices |
| Products | Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system… |
| Initiation date | Oct 3, 2018 |
| Report date | Jan 2, 2019 |
| City | Northridge |
| State | CA |
| Country | United States |
| FEI number | 3003166194 |
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: