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."

Additional context on Medtronic recalls

Medtronic has faced a series of recalls over the past few years, including several related to the company’s HeartWare Ventricular Assist Device (HVAD) System. In March 2021, for example, the company recalled HVAD pump implant kits after receiving complaints that the devices “may fail to initially start, restart or have a delay in restarting after the pump was stopped.” There were 29 complaints at the time of that recall, including two deaths and 19 serious injuries. A separate recall for those HVAD pump implant kits was announced in June 2022, and then another recall related to its batteries was announced weeks later. 

Medtronic stopped the sales and distribution of the HVAD system due to the ongoing issues in June 2021. 

Medtronic also recalled more than 450,000 of its MiniMed insulin pumps in recent years; the recall was first announced in 2019, but it was expanded in 2021. 

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Amy Baxter

Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."

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