The Recall Desk
SevereFDA (Devices)·Z-0449-2023·Announced 2022-12-21

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
  • battery-drain
  • 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 09216 8
  • (01) 3 0801902 09216 9
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category