The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0433-2023·Announced 2022-12-21

Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Battery Run-Time Issue

Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.

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: This recall is classified as Severe because it is an FDA Class I recall. Under the rubric, FDA Class I recalls never fall below score 4 due to their serious nature. The affected device is a critical cardiac support pump, and inadequate battery run-time during use could impair its function.

Plain-English summary

The Arrow AutoCAT2 Intra-Aortic Balloon Pump (IABP), model AC3 IABP NA/EMEA (reference number IAP-0600), is being recalled worldwide. There is a potential issue with short battery run-times on the affected devices.

This is a cardiac pump used to support heart function during critical care. All lot and serial numbers of this device are affected by the recall. The manufacturer is ARROW INTERNATIONAL Inc.

Patients, healthcare facilities, and medical professionals currently using these devices should contact ARROW INTERNATIONAL Inc. for guidance regarding the recall and any necessary actions. The FDA has classified this as a Class I recall.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support / Intra-Aortic Balloon Pump
Hazard

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 08495 8
  • (01) 0 0801902 08495 9
  • 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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