FDAApril 29, 2024device

Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U

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

The hazard

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

10801902172850108019021820191080190216192210801902172874

Recall history

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

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