Class I recalls indicate the devices may cause serious injuries or death, which is the most severe type of recall, according to the FDA. The recall applies to 48 individual Medtronic devices, including implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators.
These devices provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. The manufacturing defect may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest, which could result in serious injury or death.
Medtronic instructed physicians Jan. 22 to “consider prophylactic device replacement for patients who have been implanted with one of the affected devices.”
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