Abiomed, Inc. is recalling 9,177 units of its Automated Impella Controller (AIC) following reports of failure in the purge retainer component. This specific hardware failure can lead to purge pressure issues that may interfere with the proper function of the circulatory support system. To address this, the firm is initiating a voluntary correction for all affected devices distributed worldwide to ensure patient safety and device reliability. Consumers should contact Abiomed or their medical equipment distributor immediately to coordinate repairs or replacements for affected serial numbers.
A failure in the purge retainer can cause the controller to lose purge pressure or fail to maintain it correctly, potentially causing the heart pump to malfunction. This poses a critical risk to patients receiving heart support, as device failure could lead to serious medical complications or life-threatening situations.
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.
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Sources: FDA iRES · Raw API Response
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