Device recall
Z-2224-2017: Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS…
FDA device recall · Class I · Vascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-2224-2017 |
|---|---|
| Recall event | 77202 |
| Product | Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral… |
| Product code | DQY |
| Recalling firm | Vascular Solutions, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 5, 2019 |
| 510(k) numbers | K040922, K042910 |
| FEI number | 3002827704 |
At a glance
- 1–9 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