Device recall
Z-1244-2025: Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110…
FDA device recall · Class I · Bard Peripheral Vascular Inc
Key facts
| Recall number (Z-number) | Z-1244-2025 |
|---|---|
| Recall event | 96174 |
| Product | Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239 |
| Product code | MCW |
| Recalling firm | Bard Peripheral Vascular Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K172315, K211738, K242757 |
| FEI number | 2020394 |
At a glance
- 1–9 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