Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times that could affect the device's ability to provide continuous 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: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the established rubric. Short battery runtime on a cardiac support device carries serious potential risk to patient care. Although no illnesses or injuries are documented in the source material, the Class I classification itself reflects the FDA's assessment of serious hazard to patients.
Plain-English summary
Arrow International Inc. is recalling the Arrow AutoCAT2 Intra-Aortic Balloon Pump (AC3 IABP NA/AJLA, model reference IAP-0601, IPN 917288). The recall affects all lot and serial numbers of this device distributed worldwide.
The company has identified a potential issue with short battery run-times on the affected devices. An intra-aortic balloon pump is a cardiac support device that assists heart function during periods of cardiac compromise. Inadequate battery run-time could limit the device's ability to provide continuous support to patients who depend on it.
Healthcare facilities, physicians, and patients using this device should be aware of this issue. If you have this device in your facility or have concerns about its operation, contact Arrow International Inc. immediately. The U.S. Food and Drug Administration (FDA) classified this recall as Class I, its most serious classification, indicating a serious hazard to patient health.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
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) 2 0801902 17209 3
- (01) 2 0801902 17209 6
- 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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