Device recall
Z-2218-2023: TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide…
FDA device recall · Class II · Datascope Corp.
Key facts
| Recall number (Z-number) | Z-2218-2023 |
|---|---|
| Recall event | 92527 |
| Product | TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES D684-00-0546-01 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH… |
| Product code | DSP |
| Recalling firm | Datascope Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000222374 |
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