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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.
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.
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