Wayne, Pa.-based Teleflex is recalling 47,140 units of its Arrow International intra-aortic balloon pump catheters and percutaneous insertion kits following reports of serious adverse events.
The company initiated the recall because the sheath body could disconnect from its hub. Separation may result in “significant blood loss or exsanguination” or “loss of intra-aortic balloon pump treatment,” Teleflex says.
The recall — which the FDA has deemed Class 1 — follows 13 reports of adverse events, including six serious injuries and one death, according to an agency notice issued March 11.
The units were distributed to hospitals, clinics and medical centers worldwide. Teleflex initiated a worldwide recall on Feb. 9 and informed distributors and customers in a letter dated Feb. 11.
Teleflex could not be reached for comment by press time.
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