FDA Identifies Medtronic Recall of Defibrillators as Class I

US FDA has identified Medtronic’s recall of defibrillators as a Class I recall, the most serious type.

• Medtronic is recalling all ICDs and CRT-Ds, manufactured after 2017, with a glassed feedthrough, as they may deliver low or no energy output when high voltage therapy is needed; 348,616 devices recalled in US
• Medtronic issued notice to customers on May 10

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