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FDANovember 8, 2013device

Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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