Recall Z-2180-2017 ยท MAV Syringe, Balloon Inflation
Vascular Solutions, Inc.
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 device and large volume syringe (30 cc). The manually operation of the DOLPHIN is achieved by t
| Date | Apr 12, 2017 |
| Status | Terminated |
| Reason | The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to infection. |
| Root cause | Packaging |
| Action | Customers were sent a Vascular Solutions "Urgent Medical Device Removal letter" dated April 12, 2017. The letter described the problem and the product involved in the recall. Advised consignees to remove and secure all affected product and to complete and return the "VSI Account Inventory Form". For questions contact your local Vascular Solutions Sales Representative. For further questions, please call (763) 656-4300. |
| Quantity | 4,110 |
| Distribution | US Distribution including PR and to the states of : LA, TN, CA, SC, OR, WA, OK, NV, HI, OH, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042449 | DOLPHIN INFLATION DEVICE Sedat S.A., Apr 18, 2005 |