Medtech giant (and recent acquisition target) Covidien (NYSE:COV) halted shipments on certain lots of HydroFinity hydrophilic guidewires after manufacturer Nitinol Devices & Components reported a series of customer complaints.
The devices, distributed by Covidien, are used in catheter placements and other procedures for treating vascular disease. NDC issued the recall after receiving a dozen reports of damage during use, according to a press release.
The reports involved complaints of damage to the outer polymer jacket of the guidewires, raising concerns about potential embolizations, which may further result in vessel blockage or damage. One of the customer complaints involved a patient who required surgery to repair an embolization after the guidewire jacket tore off of the device.
"NDC and Covidien have taken the necessary steps to prevent future shipments of the recalled products," according to the press release. "Covidien alerted customers by letter on June 3, 2014, and is recalling all product. Unused product should be returned to Covidien."
The guidewire was distributed around the world, including the U.S., Belgium, Denmark, France, Germany, Italy, Norway, Sweden, the U.K. and Canada.