Arrow International Inc: Medical Device Recall in 2015 - (Recall #: Z-1233-2015)

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 FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle

Product Classification:

Class II

Date Initiated: February 5, 2015

Date Posted: March 11, 2015

Recall Number: Z-1233-2015

Event ID: 70436

Reason for Recall:

Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr

Status: Terminated

Product Quantity: 165 units

Code Information:

Lot Number: 18F14M0001

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Belgium

Voluntary or Mandated:

Voluntary: Firm initiated