Medtronic, battered by a high number of serious medical device recalls in recent years, says it is toughening its internal assessments for acquiring new products.
The company, operationally based in Fridley, has been hit with 11 Class I recalls in 2022 and 12 in 2021 — far more than usual. The U.S. Food and Drug Administration reserves its Class I status for the most serious, life-threatening medical device problems.
For comparison, between 2017 and 2020, Medtronic averaged about five Class I recalls a year.
