Arrow AutoCAT2 Cardiac Pump Recalled for Short Battery Run-Time Risk
Arrow International is recalling the AutoCAT2 intra-aortic balloon pump (model AEROAUTOCAT 2 WAVE) due to a potential issue with short battery run-times that may affect patient cardiac support.
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 recall classification establishes a minimum score of 4, as this designation indicates the device poses a serious potential for adverse health consequences. Although no illnesses or injuries have been reported, a cardiac support device with battery failure poses significant risk to patient safety.
Plain-English summary
The Arrow AutoCAT2 intra-aortic balloon pump (model AEROAUTOCAT 2 WAVE, ref IAP-0535, IPN000329) is being recalled worldwide. This medical device is used to provide mechanical cardiac support to patients with compromised heart function.
The device has been identified as having a potential issue with short battery run-times. This could affect the device's ability to provide adequate support during use.
Approximately 81 units have been distributed globally, affecting all lot and serial numbers of this device model. Healthcare facilities currently using this device should contact Arrow International for instructions and information on replacement options.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- short-battery-life
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 (3)
- UDI/DI (01) 0 0801902 05173 8
- (01) 0 0801902 05173 9
- All Lot/Serial Numbers
Distribution
Distribution scope not specified by the agency.
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