Device recall
Z-0087-2021: Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm…
FDA device recall · Class I · Medtronic Vascular
Key facts
| Recall number (Z-number) | Z-0087-2021 |
|---|---|
| Recall event | 86381 |
| Product | Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment… |
| Product code | DXF |
| Recalling firm | Medtronic Vascular |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 4, 2024 |
| FEI number | 1220452 |
At a glance
- None 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