Intra-Aortic Balloon Pump with Potential Short Battery Run-Times
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pumps are being recalled worldwide due to short battery run-times affecting device operation. Patients using this device should contact their healthcare provider immediately.
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: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls have a minimum severity score of 4. The issue—potential short battery run-times on a critical cardiac support device—directly affects device operability.
Plain-English summary
Arrow International Inc. is recalling the Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. This Class I recall affects all lot and serial numbers of the device, distributed worldwide (UDI/DI: 01 0 0801902 09216 8; 01 3 0801902 09216 9).
The issue involves potentially short battery run-times that could impact device operation. Patients currently using this device and healthcare facilities with these devices in inventory are affected by this recall.
If you are using or being treated with the Arrow AutoCAT2WAVE IABP, contact your healthcare provider immediately. Healthcare facilities should identify affected devices in their inventory using the provided identifiers.
The recalled product
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Category
- Medical Device — Cardiac Support
- Affected units
- 1
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 09216 8
- (01) 3 0801902 09216 9
- All Lot/Serial Numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 31 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.
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