Agency classClass IOur severity:Severe FDA (Devices)·Z-2410-2020·Announced 2020-07-08

Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially 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 AUTOCAT2 WAVE (Product Code IAP-0500). The 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. These issues may cause the device to display "System Error 3" and "High Baseline" alarms on the screen, or lead to an abrupt cessation of function or an inability to start the IABP.

The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with this defect. Affected serial number ranges are listed in the official recall notice.

The recalled product

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Manufacturer: Arrow International Inc
Category: Medical Device — Cardiovascular
Hazard: device-malfunction
vibration-failure
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 →

Same manufacturer · Arrow International Inc

See all →

High
Arrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
Severe
Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
Severe
Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
Severe
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
Severe
ARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27

Same hazard · device malfunction