Arrow International Inc. is recalling approximately 55,884 Intra-Aortic Balloon Catheter Kits, including FiberOptix, UltraFlex, and Ultra 8 models. These life-support devices may fail to inflate completely, suffer damage to the central tube, or experience helium leaks and blood entry into the helium pathway. Consumers should immediately identify if they have any of the affected catheters by checking the model and UDI numbers on the packaging.
If the balloon fails to inflate or the device breaks, it can lead to blood loss, organ damage, or the inability to provide necessary heart support, which could result in serious injury or death. The manufacturer has received reports of these issues occurring infrequently, but they require immediate attention when they manifest.
Risk identification and corrective monitoring
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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