ARROW INTERNATIONAL Inc.: Medical Device Recall in 2022 - (Recall #: Z-0428-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump

Product Classification:

Class I

Date Initiated: October 17, 2022

Date Posted: December 21, 2022

Recall Number: Z-0428-2023

Event ID: 91021

Reason for Recall:

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

Status: Ongoing

Product Quantity: 12 units

Code Information:

UDI/DI (01) 0 0801902 05174 5, (01) 0 0801902 05174 6, All Lot/Serial Numbers

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated