Medline has expanded a correction involving procedure kits containing its Medtronic aortic root cannulas, due to risk of serious injury or death.
The expanded recall comes after Medline confirmed more kit types may contain cannulas with excess material in the male luer, which could lead to severe outcomes, including delayed procedures, neurological injury, stroke or death, according to a June 23 news release from the FDA. The recall remains a correction, not a removal, meaning kits can still be used if the faulty cannula is removed and replaced.
Customers were first notified Feb. 21 and instructed to identify affected inventory and apply correction labels instructing staff to remove the recalled component prior to use.
No injuries or deaths have been reported.
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