The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0445-2023·Announced 2022-12-21

Arrow AutoCAT 2 Cardiac Pump Recalled for Potential Battery Runtime Issue

Arrow International is recalling Arrow AutoCAT 2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this as Class I, indicating a reasonable probability of serious adverse health consequences. No illnesses or deaths are reported in the source material. Although the hazard is described as potential, the FDA Class I designation combined with the critical cardiac support function of the device warrants a Severe rating per the rubric.

Plain-English summary

Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP), model REF IAP-0400F, distributed worldwide. The recall addresses a potential issue with short battery run-times on affected devices.

The intra-aortic balloon pump is a medical device that provides mechanical cardiac support. All lot and serial numbers of the affected model are included in this recall.

Healthcare providers and patients using this device should contact Arrow International for information regarding this issue and any corrective actions.

The recalled product

Product
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support
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 (3)

  • UDI/DI (01) 0 0801902 09205 2
  • (01) 3 0801902 09205 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 →

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