FDA recall Z-0441-2023

ARROW INTERNATIONAL Inc. · Class I · device

Product

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.

Distribution

Worldwide

Key facts

Status
Ongoing
Initiation date
2022-10-17
Report date
2022-12-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0441-2023