Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure
Arrow International is recalling AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working.
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 source text describes a structural defect (vibration failure) in a critical medical device that can lead to abrupt cessation of function, which aligns with the rubric criteria for a Severe (4) rating involving significant injury or property damage risks.
Plain-English summary
Arrow International Inc is recalling 2,123 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (Product Code IAP-0500I). The recall covers devices with specific serial number ranges, including 160516W, 160619W, 160804W, 160828W, 170209W through 170210W, 170302W, and 180309W. These devices were distributed worldwide.
The recall is due to a potential issue with a component within the pump that is susceptible to vibration failure. This failure can result in fretting, charring, and discoloration of the motor connector wires. Such damage may cause the device to display "System Error 3" and "High Baseline" alarms on the screen. Additionally, the device may experience an abrupt cessation of function or be unable to start.
Healthcare providers and facilities should identify affected units by checking the serial numbers against the list provided by the manufacturer. Users should stop using the affected devices and contact Arrow International Inc for further instructions on replacement or repair.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
- 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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Similar recalls
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- SevereArrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times
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