ARROW INTERNATIONAL Inc. 2022-12-21 Health critical FDA
Health · FDA · Recall #FDA-Z-0432-2023
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X… Recall
Issued December 21, 2022 · ARROW INTERNATIONAL Inc.
In December 2022, ARROW INTERNATIONAL Inc. recalled the Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
What you should do
- 1 Stop using Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ARROW INTERNATIONAL Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- ARROW INTERNATIONAL Inc.
- Category
- Health
- Recall date
- December 21, 2022
- Units affected
- Not reported
- Sold at
- Worldwide
- Recall number
- FDA-Z-0432-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- ARROW INTERNATIONAL Inc. has 5 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.