Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure
Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.
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 recall is classified as FDA Class I, which per the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences from the device's failure.
Plain-English summary
Arrow International Inc is recalling 2,123 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (Product Code IAP-0400). The recall covers devices distributed worldwide with specific serial number ranges listed in the agency notice.
The recall is due to a potential issue with a component within the device that is susceptible to vibration failure. This failure can result in fretting, charring, and discoloration of motor connector wires. These issues may cause the device to display "System Error 3" and "High Baseline" alarms, potentially leading to an abrupt cessation of function or an inability to start the pump.
Healthcare facilities and users should check their inventory for the affected serial numbers. The source text does not specify specific consumer actions beyond the recall notice, but users should contact the manufacturer or follow the instructions provided by the FDA for further guidance.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 2,123
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
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