Medtronic hit with FDA warning letter for diabetes devices
The Food and Drug Administration slapped Medtronic with a warning letter related to inadequate medical device quality requirements for its diabetes business. Specifically, the warning letter refers to issues with risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.
In July, the FDA inspected Medtronic’s Northridge facility, the headquarters for its diabetes business, after a recall of Medtronic’s MiniMed 600 series insulin pumps.
Medtronic disclosed the warning letter in a Wednesday news release, and said it would implement corrective actions and process improvements in response. However, the company shared few details on what those actions would entail.
“We are committed to fully resolving all observations as effectively and quickly as possible, Sean Salmon, president of Medtronic’s diabetes business, said in a news release. “Nothing is more important to us than providing the highest quality products to people living with diabetes.”
Recalls of the insulin pumps began in 2019, when broken retainer rings resulted in patients receiving the incorrect dose of insulin. Medtronic recently expanded the recall to include all of its MiniMed 600 series insulin pumps, to replace the retainer ring with a more durable version.
Separately, Medtronic also recalled the remote controller for its MiniMed 508 and Paradigm pumps for potential cybersecurity risks.
Medtronic’s stock fell 6% on the news Wednesday, while competitors Tandem and Insulet saw their stocks rise 10% and 5% respectively.
In a filing, Medtronic said it expects its diabetes business will be affected, with a revenue decrease in the high-single digits for the third quarter, and in the mid-single digits for fiscal year 2022. The company does not expect to change its overall earnings guidance for next year, but could potentially see a slight impact to its revenue growth in 2023.