June 18, 2014 — HydroFinity Hydrophilic guidewires have been recalled after a dozen customers complaints involving damage during use, including one patient who required surgery.
UPDATE: June 20, 2014 — Read the recall notification from the U.S. Food and Drug Administration (FDA).
The guidewires are designed with a nitinol core, a polymer jacket, and a hydrophilic coating. They are used to place catheters (long, flexible tubes) and other procedures for the treatment of vascular diseases, such as blockages in arteries, aneurysms, and blood clots.
The manufacturer, Nitinol Devices & Components (NDC), has received two reports of the outer polymer jacket to the core wire being damaged when the guidewire is withdrawn rapidly through certain delivery catheters. NDC has also received 10 reports in which the product was less severely damaged during use.
If the outer polymer jacket of the guidewire is damaged or breaks off, it can obstruct blood vessels. According to a warning from NDC:
“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.”
The distributor, Covidien, has stopped selling the recalled products. They alerted customers by letter on June 3 and provided instructions on how to return the products. The manufacturer has also alerted regulatory agencies in countries where the products were distributed, including the U.S., Belgium, Denmark, France, Germany, Italy, Norway, Sweden, UK and Canada.
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