Intra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class I medical device recall affecting a critical life-support device. However, the source text does not report any illnesses, injuries, or documented harm. The identified hazard—potential short battery run-times—is described as a potential issue without documented patient injury. Per the severity rubric, recalls with no reported illnesses and theoretical hazards score at most 3 (High).
Plain-English summary
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP) devices, REF IAP-0500J (IPN000334), are being recalled due to a potential issue with short battery run-times.
The recall affects all lot and serial numbers and applies to devices distributed worldwide. Arrow International Inc., the manufacturer, initiated this recall.
Healthcare providers and patients currently using this device should contact Arrow International Inc. for additional information and guidance. The U.S. Food and Drug Administration (FDA) classified this as a Class I medical device recall.
The recalled product
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- battery-failure
- device-failure
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 (3)
- UDI/DI (01) 0 0801902 09178 9
- (01) 3 0801902 09178 0
- All Lot/Serial Numbers
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03