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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 81
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.
Part of a larger recall action
This product is one of 31 recalled by ARROW INTERNATIONAL Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 31 products in this recall →Related recalls
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