The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices."

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 →

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