Device recall
Z-0517-2021: MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K…
FDA device recall · Class II · Medtronic Inc.
Key facts
| Recall number (Z-number) | Z-0517-2021 |
|---|---|
| Recall event | 85711 |
| Product | MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons… |
| Product code | OZO |
| Recalling firm | Medtronic Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P150001 |
| FEI number | 3003166194 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database