Due to the damage of the retaining ring, Medtronic recently expanded its recall of its MiniMed 600 series insulin pumps.
The U.S. Food and Drug Administration issued a warning letter to Medtronic, stating that its diabetes business has insufficient medical device quality requirements. Specifically, warning letters refer to issues such as risk assessment, corrective and preventive measures, complaint handling, equipment recalls, and adverse event reports.
In July, after Medtronic’s MiniMed 600 series insulin pump was recalled, the FDA inspected Medtronic’s Northridge plant, which is the headquarters of its diabetes business.
Medtronic Disclosures Warning Letter At the press conference on Wednesday, And stated that it will implement corrective actions and process improvements as a response. However, the company shared few details about what these actions will bring.
Sean Salmon, President of Medtronic’s Diabetes Business, said in a press release: “We are committed to fully addressing all observations as efficiently and as quickly as possible. High-quality products are more important. “
The recall of the insulin pump started in 2019, when the fixing ring was broken and the patient received the wrong dose of insulin.Medtronic Recently expanded the scope of the recall Includes all MiniMed 600 series insulin pumps, replacing the retaining ring with a more durable version.
In addition, Medtronic has also recalled the remote controls of its MiniMed 508 and Paradigm pumps in response to potential cyber security risks.
After the news on Wednesday, Medtronic’s stock price fell by 6%, while rivals Tandem and Insulet’s stock prices rose by 10% and 5%, respectively.
In a document, Medtronic said that it expects its diabetes business to be affected, with a high single-digit decline in revenue in the third quarter, and a mid-single-digit revenue decline in fiscal year 2022. The company does not expect to change its overall profit guidance next year, but it may have a slight impact on its revenue growth in 2023.
