Device recall
Z-1757-2019: Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm…
FDA device recall · Class I · Cook Inc.
Key facts
| Recall number (Z-number) | Z-1757-2019 |
|---|---|
| Recall event | 82888 |
| Product | Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including… |
| Product code | PNO |
| Recalling firm | Cook Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 31, 2019 |
| 510(k) numbers | K141322 |
| FEI number | 1820334 |
At a glance
- 1–9 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