Device recall
Z-0115-2023: Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4…
FDA device recall · Class II · Abbott Vascular
Key facts
| Recall number (Z-number) | Z-0115-2023 |
|---|---|
| Recall event | 90840 |
| Product | Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW US/CDS0701-XTW. For cardiac procedures. |
| 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