The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0440-2023·Announced 2022-12-21

Arrow AC3 Optimus intra-aortic balloon pump short battery runtime

Arrow AC3 Optimus cardiac pumps may experience short battery run-times. The FDA has issued a Class I recall for all units worldwide.

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 FDA Class I by the agency, which establishes a minimum severity threshold of 4 per the rubric. No deaths or hospitalizations are reported in the source material.

Plain-English summary

The Arrow AC3 Optimus intra-aortic balloon pump is subject to a Class I FDA recall due to a potential issue with short battery run-times.

Affected devices are identified by UDI/DI codes (01) 2 0801902 14277 5 and (01) 2 0801902 14277 8, as well as all lot and serial numbers of the AC3 Optimus model. The devices have been distributed worldwide.

Patients and healthcare facilities should contact the manufacturer, Arrow International Inc., or their healthcare provider regarding this recall for information about potential remedies or alternatives.

The recalled product

Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac 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) 2 0801902 14277 5
  • (01) 2 0801902 14277 8
  • 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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