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| Hydrofinity Hydrophilic Guidewire--Courtesy of Covidien |
The FDA slapped its most severe label on Nitinol Devices & Components' recalled HydroFinity Hydrophilic Guidewires, meaning the agency believes "there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
The agency received 12 reports of device malfunction due to tearing or damage to the wire's outer polymer jacket, which can result in blocked blood flow (embolization) or damaged or blocked blood vessels (occlusion).
Two of the adverse events resulted in injuries and one required surgical intervention, FDA said. In addition, in two cases the entire polymer jacket separated from the device.
NDC initiated a voluntary recall of the device on June 18 and the Class I recall label from the FDA adds to the sense of urgency. Covidien ($COV), the product's distributor, informed customers of the problem via letter and is also recalling the product.
FDA urged hospitals to stop using the guidewire, remove it from inventory and send unused devices to Covidien. The recall notice also contains the affected model numbers.
The guidewire is used to maneuver and place catheters and diagnostic devices during invasive surgery. Nitinol is an alloy made of nickel and titanium and is the primary material of many stents, as well as the guidewire.
- read the recall notice