In 2022, Medtronic recalled over 85,000 implantable defibrillators due to a technical malfunction that could prevent them from delivering the necessary high-voltage shock to reset the heart’s rhythm. A study by researchers from Harvard, Yale, and the University of California San Francisco analyzed FDA documents over a decade and found that only 30 out of 157 cardiovascular devices that were recalled for serious injury or death risks had clear evidence of premarket clinical testing. This raises concerns about the lack of testing before these devices are used on patients, highlighting potential risks associated with cardiovascular device recalls.
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Most recalled heart devices weren’t tested in patients
