Recall Z-0441-2023— ARROW INTERNATIONAL Inc.

Name: FDA recall Z-0441-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-17

Class I · Ongoing

Class I FDA medical device recall by ARROW INTERNATIONAL Inc., initiated 2022-10-17. It names one FDA 510(k) clearance: K201112. Product: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump. Reason: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices..

Recalling firm: ARROW INTERNATIONAL Inc.
Classification: Class I
Status: Ongoing
Initiated: 2022-10-17
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.·cleared 2020-05-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.