FDA warning letter cites product safety issues

The agency was critical of how long Medtronic took to recall certain MiniMed insulin pumps, despite over 57,000 medical device reports being filed with the FDA over more than three years.

The FDA flagged several product safety problems in a December warning letter to Medtronic’s diabetes group, citing the medical device maker for not appropriately classifying patient risks for faulty MiniMed insulin pump devices and for not initiating a recall despite tens of thousands of medical device reports made to the agency over three years.

Read full article at Medtechdive

https://www.medtechdive.com/news/fda-warning-letter-medtronic-diabetes-group/616665/