Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
Reported: December 21, 2022 Initiated: October 17, 2022 #Z-0431-2023
Product Description
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), 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
- 81 units
- Distribution
- Worldwide
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump. Recalled by ARROW INTERNATIONAL Inc.. Units affected: 81 units.
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-0431-2023.
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