Medtronic Plc (NYSE:MDT) received a warning letter from the Food and Drug Administration highlighting certain concerns related to medical device quality requirements at the Company's diabetes business headquarters.
The Company said that the letter focused on inadequacies in risk assessment, complaint handling, and device recalls at Medtronic's facility in Northridge, California.
Medtronic said the letter was issued following an inspection last July related to recalls of MiniMed 600 insulin infusion pumps and a remote controller device for certain other pumps.
The Company had later said it would replace all pumps with clear retainer rings with another design, regardless of whether they were damaged or not.
Last week, Medtronic's Covidien unit initiated a recall of Puritan Bennet 980 series ventilators due to a manufacturing error.
The recall was initiated due to a "manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use," according to an entry in the FDA recall database.
The recall, which was initiated on November 4, affects 278 units.
"We are committed to fully resolving all observations as effectively and quickly as possible. Nothing is more important to us than providing the highest quality products to people living with diabetes," said Medtronic official Sean Salmon.
To ensure the most effective response to the warning letter, the company adds, Medtronic will apply resources from across the company and utilize external experts. The company is implementing a range of corrective actions and process improvements related to the observations, and will continue reviewing these actions with the FDA.
MDT shares tumbled $6.99, or 6.3%, to $104.70.
