Medtronic recalls heart valve implant device

Medical device maker Medtronic has recalled 7,300 devices used to implant heart valves after receiving reports that the systems contained particles that could cause health problems

The Evolut R transcatheter ­aortic valve and the special kit used to implant it were approved for ­commercial sale in the US last June.

Medtronic spokeswoman, Wendy Dougherty, said: “In the US no affected loading systems had been released commercially.

“All of the affected loading systems have already been removed from the market.

“Most importantly, there had been no reports of any adverse patient effects due to this issue and no further action is required of health care professionals.”

She cautioned that the recall affected just the 74 product lots listed in the notice sent to doctors last month.

On Wednesday, the Food and Drug Administration (FDA) characterised the letter as a Class I recall because the agency decided there was a reasonable probability of adverse health consequences if the device is used.

The Evolut R is among a high-growth class of devices called transcatheter aortic valve replacements, which allow doctors to implant new heart valves without open-chest ­surgery.

It’s approved to treat patients whose aortic valves are so severely narrowed that they limit the flow of blood through the heart, potentially leading to heart failure.

The valve itself was not recalled but the company received eight reports of particulate matter in the EnVeo R Loading System that is used to implant the valve in the heart.

It is thought that the particles could have caused an embolism in a patient’s blood stream.

According to Dougherty the issue has been resolved “with the introduction of a process improvement in ­manufacturing.”