Device recall
Z-2180-2017: Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide…
FDA device recall · Class II · Vascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-2180-2017 |
|---|---|
| Recall event | 77095 |
| Product | Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation… |
| Product code | MAV |
| Recalling firm | Vascular Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2018 |
| 510(k) numbers | K042449 |
| FEI number | 3002827704 |
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