The Recall Desk
HighFDA (Devices)·Z-0427-2023·Announced 2022-12-21

Arrow AutoCAT2 Intra-Aortic Balloon Pump: Short Battery Run-Time Issue

Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.

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: FDA Class I designation indicates serious potential risk. However, no illnesses or injuries have been reported, and the hazard is characterized as potential rather than confirmed. Score reflects the theoretical nature of the risk despite the serious classification.

Plain-English summary

Arrow International has recalled 6 refurbished Arrow AutoCAT2 Intra-Aortic Balloon Pumps (IABP) due to a potential issue with battery run-times. The affected devices are identified by UDI/DI codes (01) 0 0801902 09375 2 and (01) 0 0801902 09375 3, covering all lot and serial numbers.

Intra-aortic balloon pumps are cardiac support devices used to assist heart function during medical procedures and in critical care settings. A potential issue affecting battery run-times could impact the device's ability to provide sustained support during patient treatment.

The recall covers refurbished units distributed worldwide. No reports of injury or death related to this issue have been disclosed in the recall notice.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support Device
Hazard
Affected units
6

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 09375 2
  • (01) 0 0801902 09375 3
  • 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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