Device recall
Z-0116-2023: Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR…
FDA device recall · Class II · Abbott Vascular
Key facts
| Recall number (Z-number) | Z-0116-2023 |
|---|---|
| Recall event | 90840 |
| Product | Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW, MitraClip G4 Clip Delivery… |
| Product code | NKM |
| Recalling firm | Abbott Vascular |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3004635528 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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