The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0441-2023·Announced 2022-12-21

Arrow AC3 Optimus Intra-Aortic Balloon Pumps recalled for short battery runtime

Arrow International is recalling Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. The pumps may not operate for the intended duration during critical cardiac care.

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 is an FDA Class I recall. Per the severity guidelines, FDA Class I recalls require a minimum severity score of 4. Although no illnesses or injuries are currently reported, an FDA Class I classification for a critical cardiac support device with potential battery runtime issues indicates a reasonable probability of serious health consequences if the device fails during critical use.

Plain-English summary

Arrow International Inc. is recalling the Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP), model AC3 Optimus IABP NA/AJLA, reference number IAP-0701 (IPN001113), due to a potential issue with short battery run-times. The affected devices have been distributed worldwide.

Intra-aortic balloon pumps are critical care medical devices used to provide mechanical support to the heart during and after cardiac procedures. If the battery run-time is shorter than intended, the device may not continue to operate for the full duration needed during a procedure, potentially affecting patient care.

Healthcare providers and patients using these devices should contact Arrow International Inc. for information about the recalled devices. Providers should verify battery status and available runtime on their devices and follow Arrow's recommendations for managing patient care during procedures using the affected equipment.

The recalled product

Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac / 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 09125 3
  • (01) 0 0801902 09125 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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