Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure
Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component issue that may cause 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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of…"
Plain-English summary
Arrow International Inc. is recalling 2,123 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (Product Code IAP-0500NL) distributed worldwide. The recall involves specific serial number ranges: 160714W through 160715W and 160918W.
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 the motor connector wires. These conditions may cause the pump to display "System Error 3" and "High Baseline" alarms on the screen, potentially leading to an abrupt cessation of function or an inability to start the IABP.
The source text does not specify specific instructions for consumers or healthcare providers regarding immediate actions to take, such as stopping use or contacting a representative, beyond the identification of the affected serial numbers.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 2,123
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 (1)
- Serial Number Ranges: 160714W through 160715W 160918W
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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