July 18, 2023

FDA: Class I recall of Medtronic implantable cardioverter, cardiac resynchronization therapy defibrillators

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA), on July 18, identified the recall by Medtronic of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious.

Medtronic is recalling all ICDs and CRT-Ds, with glassed feedthroughs that were manufactured after 2017, as they may deliver low or no energy output when high voltage therapy is needed because of inappropriate activation of the short circuit protection feature. The issue is more likely to occur with devices that are configured to deliver therapy in the AX>B delivered pathway.

The company reports 28 incidents, 22 injuries, and no deaths related to this issue.

Distribution dates were October 13, 2017, to June 9, 2023.


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