Medtronic recalls more than 1 million catheters in U.S. over defect

Medtronic has recalled more than 1 million catheters used for hemodialysis, which filters waste, salt and fluid from a patient's blood.

Last week the FDA labeled the action a Class 1 recall, the agency's most serious classification.

The devices are being recalled due to a catheter hub defect which could potentially cause leaking.

More than 1.03 million catheters under the Palindrome and Mahurkar brands are being recalled. Some of the catheters were distributed as recently as May 11.

Medtronic initiated the recall June 8 when it sent out a letter to affected customers. There has been only one complaint about the product. There have been no reports of injury or death.

The company's recall notification was issued to health care providers using the catheters and patients who have a defective catheter implanted.

"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," said Pamela Lee, a spokeswoman for Medtronic.

Lee added, "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 notice lists the catheter manufacturer as Covidien LLC. Covidien was an Ireland-based medical device and surgical supply company. Medtronic acquired Covidien in 2015.