FDAApril 12, 2017device
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 de...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
vascular solutionsvascular
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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