Datascope Corp. has recalled approximately 18,350 Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) due to a critical defect where the devices experience autofill failure conditions. This defect causes the pump to stop unexpectedly, which can interrupt life-sustaining circulatory support for patients. These devices were distributed worldwide and across the United States between various production dates for all lot numbers of the affected models.
When the autofill failure occurs, the pump stops delivering necessary mechanical support to the heart. This sudden interruption in therapy can lead to severe health consequences, including organ damage, unstable blood flow, or death, depending on the patient's reliance on the device.
Manufacturer mitigation and notification
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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