Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Component Vibration Failure
Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component vibration issue may cause 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 involves a critical medical device (Intra-Aortic Balloon Pump) where a failure could lead to abrupt cessation of function, which constitutes a significant risk of harm to patients.
Plain-English summary
Arrow International Inc. is recalling 2,123 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (Product Code IAP-0500E). 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.
The component issue may cause the pump to display "System Error 3" and "High Baseline" alarms on the screen. It may also result in the abrupt cessation of function or an inability to start the IABP. The affected devices were distributed worldwide.
The source text does not specify specific instructions for consumers or healthcare providers regarding the immediate handling of these devices. Users should refer to the official FDA recall notice for specific guidance on how to proceed.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
- 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
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- SevereArrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Battery Runtime Issues
FDA (Devices) · 2022-12-21
- SevereArrow AutoCAT2 Intra-Aortic Balloon Pump recalled for short battery run-times
FDA (Devices) · 2022-12-21
- SevereIntra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue
FDA (Devices) · 2022-12-21
- SevereArrow AutoCAT2WAVE Intra-Aortic Balloon Pump recalled for short battery runtime
FDA (Devices) · 2022-12-21
- SevereArrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Short Battery Run-Time
FDA (Devices) · 2022-12-21
- SevereArrow AutoCAT2 Intra-Aortic Balloon Pump short battery run-time issue
FDA (Devices) · 2022-12-21