The US Food and Drug Administration (FDA) issued two warning letters to Medtronic on Tuesday related to manufacturing nonconformities that resulted in a defibrillator recall earlier this year.
The recall of the Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) models was initiated in January “due to a defect in the manufacturing process,” FDA said, identifying this as a Class I recall. The defect “causes an out of specification gas mixture inside the device,” according to the February notice.
The site inspections that were then conducted by FDA investigators at two Medtronic manufacturing facilities have now resulted in warning letters, including one issued to the Medtronic Cardiac Rhythm and Heart Failure (CRHF) business in Minnesota and a second to the site associated with the recall—the Medtronic Puerto Rico Operations Company (MPROC). A good manufacturing practices (GMP) violation at this site in Juncos, Puerto Rico was identified as the cause of the recall in both FDA warning letters.
“The warning letters do not impact patients or physicians, and no new action is required by them as all potentially affected devices related to this issue were voluntarily recalled in January and March 2018,” Kathleen Janasz, director of communications at CRHF, told Focus. “There have been no reports of patient death related to the issues identified in the letters. However, Medtronic has confirmed one device failure, which resulted in the loss of device functionality.”
Read More at the Source: FDA Warnings Reveal Manufacturing Problems That Caused Medtronic to Recall ICDs | RAPS
By: Ana Mulero
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