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Defective medical device may require surgical correction

Product recalls affecting Nashville residents occur regularly. Many of these are preventative and address a minor potential for injuries or property damage. In some instances, however, the problems associated with a product defect cannot be easily rectified. For such cases, extreme measures may be necessary to correct the issue, such as invasive surgical procedures.

A medical product recall has been issued for a device used in vascular disease treatment, and in some instances surgery may be required to correct the problem.

HydroFinity Hydrophilic Guidewires—produced by the California-based Nitinol Devices and Components, Inc.—is used in various procedures, including the placement of catheters. Over ten instances have surfaced in which these devices have been damaged while being used. One of the problems that may occur with this defective product is vessel occlusion, which can require surgery to rectify. Thus far, one person has needed surgery after using this device.

Those who experience adverse effects from using these guidewires are being asked to report them to the U.S. Food and Drug Administration. This can be done via the agency’s website, fax or regular mail. Consumers looking for more information can contact NDC’s customer service. The company is asking that unused products be returned to Covidien, the product’s distributor.

When defective medical devices have negative health implications that require an invasive surgical procedure to correct, financial and emotional issues may result. Those who have been injured after using a recalled medical product may want to discuss their situations with an attorney. This can help them determine whether they can recover some of their lost wages and medical expenses by filing a suit against the manufacturer.

Source: FDA.gov, “NDC Implements Voluntary Recall of the Hydrofinity Hydrophilic Guidewire,” June 18, 2014. 

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