Medtronic is recalling more than 1 million dialysis catheters because of a malfunction that can potentially cause the devices to leak while in use.
The company is recalling nine different dialysis catheter products that comprise about 1.02 million affected units, according to the Food and Drug Administration. The recall, initiated on June 8, is for Medtronic’s Covidien subsidiary.
Medtronic said in an emailed statement today that "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."
The FDA labeled the recall for each product as Class I, which is the agency’s most severe classification, and united all the products into one recall event.
The regulator listed the same reason for recalling each product: “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.”
Medtronic sent customers the recall notification by mail on June 8, according to the FDA. The letter told customers to “immediately quarantine and discontinue use” of the affected products and to return them to Medtronic.
The company also asked that any reports of adverse events associated with the product be reported to the FDA.
The recall includes several models of Palindrome Chronic catheters and one model of the Mahurkar Chronic Carbothane catheter.
The warning letter is the latest product safety problem for the medtech firm. Along with the most recent recall, the FDA has posted seven Class I recall notices this year. In 2021, the agency posted 10 Class I recall notices for the company.
Medtronic also stopped selling and distributing the HeartWare Ventricular Assist Device (HVAD) cardiac pump in June 2021 after numerous recalls, while its diabetes unit received an FDA warning letter in December because of product safety problems.
The warning letter has delayed the review of two key diabetes products for Medtronic, while rivals have launched new products and grown their share of the diabetes technology market.
CEO Geoff Martha addressed the ongoing recalls in January, calling it his top priority. Still, the company has had multiple Class I recalls since including further recalls for the HVAD pump that had already been pulled from the market.
