Medtronic recalls more than 1M dialysis catheters

Medtronic is recalling more than 1 million dialysis catheters due to a potential leak malfunction.

The Food and Drug Administration (FDA) shared information on the recall on its website. This is a Class I recall, which means using the devices could cause "serious adverse health consequences or death."

Medtronic notified customers of the recall on June 8. The customers were instructed to immediately quarantine and discontinue the use of specific lots of chronic hemodialysis catheters and return them to Medtronic. Customers are also asked to report any instances of adverse events associated with the product to the FDA.

“There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use,” the FDA noted in its announcement.

Medtronic comments on the recall

"Medtronic recently issued a voluntary medical device recall related to specific lots of chronic hemodialysis catheters because of a potential leaking condition in the catheter hub which may result in unanticipated fluid return during use," the company said in an emailed statement about the June 2022 catheter recall. "There have been no reports of patient harm at this time and product retrieval is underway. The root cause of the matter is under investigation and Medtronic has notified all applicable regulatory agencies."