Medtronic Plc (NYSE:MDT) received a warning letter from the FDA 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 in July 2021 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.
- Related Link: Medtronic To Face Class Action Suit From Canadian Users Of MiniMed Insulin Pumps.
- 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.
- Price Action: MDT shares are down 4.56% at $106.60 during the premarket session on the last check Wednesday.
