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

Recall date

November 8, 2013

Source

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

Recall number

Z-1259-2015

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.

Why it was recalled

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

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

What was recalled

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