Arrow International Inc: Medical Device Recall in 2013 - (Recall #: Z-1065-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

Product Classification:

Class II

Date Initiated: November 27, 2012

Date Posted: April 17, 2013

Recall Number: Z-1065-2013

Event ID: 64527

Reason for Recall:

Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

Status: Terminated

Product Quantity: 637 units

Code Information:

Lot Numbers: KF2073694 KF2083874 KF2083966 KF2094179 KF2073788 KF2083927 KF2084059

Distribution Pattern:

Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated