One month into 2024, the FDA has already issued recalls for several medical devices, surgical devices, masks and medication.
Here are two cardiology-focused recalls in the last six months:
1. Getinge recalled its Cardiohelp system, which helps blood and remove carbon dioxide from blood, due to a possible blocking or impairment of the ability of the emergency drive to be cranked. The emergency drive can become stuck or difficult to turn due to friction being generated in the handle attachment. Getinge issued a Class I recall — the most serious recall.
2. Medtronic recalled its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, intended to monitor and regulate heart rate and rhythm, due to low or no energy output. A reduced-energy shock, or no shock at all, may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury or death. Medtronic issued a Class I recall and reported 28 incidents, 22 injuries and no deaths for this issue.