Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Runtime Recall
The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Although no injuries have been reported, FDA Class I recalls require a minimum severity score of 4 per established criteria, as they indicate a reasonable probability that device use could cause serious adverse health consequences.
Plain-English summary
The Arrow AutoCAT2 Intra-Aortic Balloon Pump (IABP), model AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X, has been recalled by the U.S. Food and Drug Administration. The device is used in cardiac care to support heart function. According to the FDA, there is a potential issue with short battery run-times on affected units.
The recalled devices have been distributed worldwide. All lot and serial numbers are included in this Class I recall. Healthcare facilities and medical centers using this device should review this recall notice.
Patients and healthcare providers should discuss any concerns about device battery performance with the device manufacturer or their healthcare provider. Questions about this recall should be directed to Arrow International Inc.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- battery-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI (01) 0 0801902 05173 8 (11) 170825 (21) 999999W
- All Lot/Serial Numbers
Distribution
Distribution scope not specified by the agency.
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