The Recall Desk
SevereFDA (Devices)·Z-0447-2023·Announced 2022-12-21

Arrow AutoCAT2WAVE intra-aortic balloon pump recalled for short battery run-times

Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled for a potential issue with short battery run-times. The FDA Class I recall affects 39 units distributed worldwide, manufactured by Arrow International Inc.

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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. Although no adverse events have been reported, battery failure on a critical cardiac support device used in acute medical situations carries serious potential risk.

Plain-English summary

Arrow AutoCAT2WAVE intra-aortic balloon pumps (IABP) manufactured by Arrow International Inc. are being recalled for a potential issue with short battery run-times. The affected model is IAP-0500D (IPN000321). Intra-aortic balloon pumps are cardiac support devices used in acute medical situations.

The recall affects 39 units that were distributed worldwide. All lot and serial numbers of the affected model are included in this FDA Class I recall. The specific device identifiers are (01) 0 0801902 09217 5 and (01) 3 0801902 09217 6.

Healthcare facilities and individuals with these devices should contact Arrow International Inc. for information regarding this recall.

The recalled product

Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support
Hazard
Affected units
39

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 09217 5
  • (01) 3 0801902 09217 6
  • 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.

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Same hazard · battery failure

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