Medical device and MedTech insights, news, tips and more

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

A Speciality Recruiting Firm Exclusively Servicing The Medical Device Industry

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.