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| Hydrofinity Hydrophilic Guidewire--Courtesy of Covidien |
Covidien ($COV) has issued a recall of its Hydrofinity Hydrophilic Guidewire due to the potential for damage to the outer polymer jackets of the device during use. The company said it has notified the FDA of the action.
The guidewire, manufactured for the Irish devicemaker by Nitinol Devices & Components of Fremont, CA, was designed for easy navigation through the anatomy during catheter placement and other procedures to treat vascular diseases.
"Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage," the company said in a release distributed by Nitinol Devices.
Two cases were reported where the coating to the core wire was damaged when the guidewire was withdrawn rapidly. There were ten incidents when less severe damage was reported during use, the company said. In one case surgery was required to correct the problem.
Customers were alerted by Covidien of the potential damage in a recall letter sent June 3, and regulatory agencies in Canada and in several European countries were also notified. The company has asked U.S. customers to report any problems with the device to the FDA's MedWatch Adverse Event Reporting program. The agency has yet to weigh in on the recall with a class status.
In April, Covidien issued a recall of more than 650 units of its Pipeline Embolization Device and Alligator Retrieval Device due to concerns over the coating on their delivery wires, which could delaminate and detach from the device.
The recall comes in the wake of last week's announcement that Medtronic ($MDT) will buy Covidien for $42.9 billion in cash and stock.
- read the release