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FDA designates transseptal needle recall due to plastic fragments as class 1

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The FDA has designated Cook Medical’s product recall of a transseptal needle as a class 1 recall, the most serious kind. The recall affects 97 needles manufactured and distributed between April 23, 2018 and November 5, 2018.

A manufacturing error of the transseptal needle (Cook Medical) caused some products to have missing back bevels that created a sharp tip, which could damage the inside of an introducer sheath and detach plastic fragments, according to a MedWatch report from the FDA. The fragments can enter a patient’s bloodstream and result in longer procedure times, embolism, blood vessel wall injury, stroke or death.

Cook Medical distributed a notification letter to affected customers on Feb. 1, 2019, alerting them to identify and remove any affected needles, return them to the company and contact the company for further information and support.