|The FDA is blocking Medtronic from importing its Amphirion Plus catheter.--Courtesy of Medtronic|
The FDA is barring Medtronic ($MDT) from importing two catheters made by an Italian subsidiary, a response to serious manufacturing problems at an overseas plant.
In a February inspection of Medtronic unit Invatec's Italian facility, the FDA cited manufacturing, safety and process problems with the Amphirion Plus and Diver CE angioplasty catheters. Unsatisfied with the company's response, the agency has issued a warning letter and will not allow further importation of the devices.
According to the FDA, Invatec promised to revise its process validation procedures and retrain its personnel to comply with agency regulations, but because the company never submitted its proposed changes for FDA review, the agency has elected to halt Amphirion Plus and Diver CE from entering the U.S.
"Given the serious nature of the violations of the act, ... FDA is taking steps to refuse entry of these devices into the United States, known as 'detention without physical examination,' until these violations are corrected," the agency wrote.
The FDA's letter, posted on its website Tuesday, is dated May 6, and a Medtronic spokesman said the company has already issued a response and is working with the agency to resolve the problems.
Medtronic is taking the FDA's concerns "very seriously," spokesman Joseph McGrath said in an email to FierceMedicalDevices, and the company expects to keep selling both catheters in the U.S. and abroad, with no material impact on revenue resulting from the import ban.
"Most importantly, no action by clinicians or patients is required as a result of the letter," McGrath wrote. "In addition, we are confident that the items covered in the letter do not adversely impact products in our distribution channels or in customer inventory."
- read the warning letter
Editor's note: This story has been updated to include comments from Medtronic.