Arrow International Inc: Medical Device Recall in 2015 - (Recall #: Z-1259-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 8, 2013

Date Posted: March 18, 2015

Recall Number: Z-1259-2015

Event ID: 70603

Reason for Recall:

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

Status: Terminated

Product Quantity: 166 units

Code Information:

Lot Number: KF1111796 Exp. Date: 11/30/2013

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated