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 the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
This recall has been terminated (originally issued April 12, 2017).
- Company
- Vascular Solutions, Inc.
- Recall Initiated
- April 12, 2017
- Terminated
- April 11, 2018
- Recall Number
- Z-2180-2017
- Quantity
- 4,110
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution including PR and to the states of : LA, TN, CA, SC, OR, WA, OK, NV, HI, OH, TX.
Lot / Code Info
Lot Numbers: 15075668, 15075924, 15115426, 15125175, 16025324, 16035493, 16055261.
Root Cause
Packaging
Action Taken
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.