NDC Implements Voluntary Recall of the Hydrofinity™ Hydrophilic Guidewire

Date of Recall

2014-06-18

Recall Details

- FREMONT, CA - June 18, 2014 - Nitinol Devices & Components, Inc. (NDC) announced today a voluntary recall of its HydroFinity™ Hydrophilic Guidewires. The HydroFinity Guidewire is a product developed and manufactured by NDC and distributed by Covidien. It is a nitinol-core, polymer-jacketed guidewire with a hydrophilic coating intended for use in catheter placement and other procedures to treat vascular diseases.

NDC is conducting this recall due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. Vessel occlusion may necessitate surgical intervention to resolve. Two cases were reported where the polymer jacket separated from the device and embolized. One case required surgical intervention.

NDC and Covidien have taken the necessary steps to prevent future shipments of the recalled products. Covidien alerted customers by letter on June 3, 2014 and is recalling all product. Unused product should be returned to Covidien. Additionally, NDC has notified regulatory agencies in the countries where the HydroFinity Guidewire is distributed: U.S., Belgium, Denmark, France, Germany, Italy, Norway, Sweden, UK and Canada.

NDC has apprised the U.S. Food and Drug Administration (FDA) of this action. Any adverse events experienced with the use of this product and/or quality problems should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

• Online: www.fda.gov/medwatch/report.htm (form available to fax or mail), or
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

For information or to report a problem, please contact NDC Customer Service at 1-510-683-2000 Monday - Friday between the hours of 8:00 am and 5:00 pm PST or email [email protected].

ABOUT NDC

NDC is a technically-driven contract manufacturer of Nitinol-based medical devices headquartered in Fremont, Calif. NDC has a proven, 20-year track record of partnering with the medical device community and delivering high-quality Nitinol devices and components.

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