Device recall
Z-1490-2022: Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization…
FDA device recall · Class I · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Key facts
| Recall number (Z-number) | Z-1490-2022 |
|---|---|
| Recall event | 90565 |
| Product | Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1 |
| Product code | NIK |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P010031, P010031S674 |
| FEI number | 2182208 |
At a glance
- None Linked 510(k)s
- 1–9 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