Medtronic Faces Class I Recall As FDA Flags Heart Vent Catheter Performance Risk

A Class I Recall Places Medtronic’s Cardiac Catheter Manufacturing And Quality Controls Under Closer Scrutiny.

 
• By Shubham Singh
  
Medtronic said in its letter that no patient deaths have been reported until July 28 but warned that fatalities could occur if the device were to cause a complicated perforation of critical heart tissue that goes unnoticed or untreated.

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