Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Run-Time Issue
ARROW INTERNATIONAL is recalling Arrow AutoCAT2 Intra-Aortic Balloon Pumps due to a potential issue with short battery run-times. Affected devices distributed worldwide may have reduced battery endurance.
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 FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls must score at least 4 (Severe). No illnesses or injuries have been reported in the source material, so this does not escalate to Critical (5), but the Class I designation establishes the Severe (4) minimum.
Plain-English summary
ARROW INTERNATIONAL Inc. is recalling the Arrow AutoCAT2 Intra-Aortic Balloon Pump (model AC3 IABP NA/EMEA, REF IAP-0600), distributed worldwide. All lot and serial numbers are affected.
The recall addresses a potential issue with short battery run-times on the affected IABP devices. Intra-aortic balloon pumps are cardiac support devices used in acute care settings. Reduced battery endurance could compromise the device's continued operation during critical cardiac support.
This is an FDA Class I recall, indicating a serious hazard situation. The recall applies to all affected devices regardless of lot or serial number.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- 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 17208 6
- (01) 2 0801902 17208 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 →Related recalls
Same manufacturer · ARROW INTERNATIONAL Inc.
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Same hazard · short battery runtime
See all →- SevereArrow AutoCAT2 cardiac pump recalled for short battery run-times
FDA (Devices) · 2022-12-21
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