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Arrow International Inc recalls Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Recalled March 18, 2015 · FDA recall Z-1259-2015 · Arrow International
Hazard
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere. · FDA Class II
Units
166 units
Sold at
Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
Description
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Product
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Manufacturer(s)
Arrow International Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →