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 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-0400E). The recall is due to a potential issue with a component that is susceptible to vibration failure. This failure can result in fretting, charring, and discoloration of the motor connector wires.
The affected devices may display "System Error 3" and "High Baseline" alarms on the screen. These issues may lead to the abrupt cessation of the pump's function or an inability to start the device. The recall covers units with specific serial number ranges, including 150301V, 160119V, 160429V through 160430V, 160634V, and 160643V.
The affected products were distributed worldwide. The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- 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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