The Recall Desk
HighFDA (Devices)·Z-0430-2023·Announced 2022-12-21

Arrow AutoCAT2 Intra-Aortic Balloon Pump short battery run-time issue

Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.

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: This is an FDA Class I recall for a critical cardiac support device with no reported illnesses or injuries. The hazard—short battery run-times—is described as a potential issue, indicating risk of harm to patients without documented actual harm. Per the severity rubric, when an FDA Class I device presents a theoretical hazard with no reported illness, the maximum score is 3.

Plain-English summary

Arrow International is recalling 88 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X, IPN000328) distributed worldwide.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. The IABP is a cardiac support device used to assist heart function during medical procedures.

The affected devices are identified by UDI/DI codes (01) 0 0801902 09391 2 and (01) 0 0801902 09391 3, with all lot and serial numbers included. The FDA classified this as a Class I recall.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support Device
Hazard
  • battery-failure
  • device-malfunction

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 09391 2
  • (01) 0 0801902 09391 3
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

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