
Canadian healthcare regulators issued notice that Medtronic (NYSE:MDT) has asked for the return of all NC Sprinter Rx balloon dilation catheters from a single lot after discovering that the devices are mislabeled.
A compliance chart packaged with the lot incorrectly references a 2.5 mm balloon diameter, but the contained devices are 2.25 in diameter, according to the Health Canada memo.
The Canadian healthcare regulators gave the measure Type III Hazard Classification, referring to "a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences."
The device maker has asked for the return of NC sprinter Rx balloon dilatation catheters, Model NCSP22512X, from lot number 207002011, according to the regulatory notice.