The Recall Desk
SevereFDA (Devices)·Z-0432-2023·Announced 2022-12-21

Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Runtime Recall

The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.

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: FDA Class I medical device recall. Although no injuries have been reported, FDA Class I recalls require a minimum severity score of 4 per established criteria, as they indicate a reasonable probability that device use could cause serious adverse health consequences.

Plain-English summary

The Arrow AutoCAT2 Intra-Aortic Balloon Pump (IABP), model AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X, has been recalled by the U.S. Food and Drug Administration. The device is used in cardiac care to support heart function. According to the FDA, there is a potential issue with short battery run-times on affected units.

The recalled devices have been distributed worldwide. All lot and serial numbers are included in this Class I recall. Healthcare facilities and medical centers using this device should review this recall notice.

Patients and healthcare providers should discuss any concerns about device battery performance with the device manufacturer or their healthcare provider. Questions about this recall should be directed to Arrow International Inc.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac / Intra-Aortic Balloon Pump
Hazard
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 (2)

  • UDI/DI (01) 0 0801902 05173 8 (11) 170825 (21) 999999W
  • 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.

See all 31 products in this recall →

Related recalls

Same manufacturer · ARROW INTERNATIONAL Inc.

See all →

Same hazard · battery defect

See all →