FDA Issues Class I Recall to Boston Scientific’s RotaWire Elite Guidewire and wireClip Torquer Guidewire
Last month, the FDA issued a Class I recall to Boston Scientific’s RotaWire Elite Guidewire and wireClip Torquer Guidewire because the core wires may crack and separate from the rest of the Rotablator Rotational Atherectomy System. This device is used to open narrowed arteries and improve blood flow to the heart, when patients undergo atherectomy procedures.
Boston Scientific has received several reports of the guidewires cracking while using the device. One of these reports included one patient death following medical intervention to remove the broken wire.
The RotaWire Elite Guidewires and wireClip Torquer Guidewires recalled were 600 units in 17 states, which included California, New York, Texas, and Washington. These guidewires were manufactured between June 26, 2015 and September 10, 2015 and distributed between July 9, 2015 to October 1, 2015. Below is a full list of the affected devices:
Boston Scientific notified customers of the guidewires beginning in October 9, 2015 warning to stop distributing and using the devices immediately.
If you or a loved one has been injured by RotaWire Elite Guidewire and wireClip Torquer Guidewire, contact our medical device attorneys here at The Brandi Law Firm to discuss your potential case and any legal remedies you may have.
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