Device recall
Z-2195-2024: CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter…
FDA device recall · Class II · Medtronic Inc.
Key facts
| Recall number (Z-number) | Z-2195-2024 |
|---|---|
| Recall event | 94674 |
| Product | CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator |
| Product code | NIK |
| Recalling firm | Medtronic Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P010031, P010031S674 |
| FEI number | 2182208 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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