Vascular Solutions, Inc. recalls Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflat…

Recall date

April 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2180-2017

FDA classification

Class II

Brand / firm

Vascular Solutions, Inc.

Sold / distributed

US Distribution including PR and to the states of : LA, TN, CA, SC, OR, WA, OK, NV, HI, OH, TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.