2 recent cardiology recalls

One month into 2024, the FDA has already issued recalls for several medical devices, surgical devices, masks and medication. 

Advertisement

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. 

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Advertisement

Next Up in Cardiology

Advertisement

Comments are closed.