PlainRecalls
FDA Devices Critical Class I Ongoing

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump

Reported: December 21, 2022 Initiated: October 17, 2022 #Z-0437-2023

Product Description

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump

Reason for Recall

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

Details

Recalling Firm
ARROW INTERNATIONAL Inc.
Units Affected
N/A
Distribution
Worldwide
Location
Morrisville, NC

Frequently Asked Questions

What product was recalled?
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump. Recalled by ARROW INTERNATIONAL Inc.. Units affected: N/A.
Why was this product recalled?
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 21, 2022. Severity: Critical. Recall number: Z-0437-2023.