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 [...]

December 1st, 2015|Drug and Medical Device Litigation|0 Comments

Class I Recall for Stryker’s OASYS Midline Occiput Plate

On August 29, 2013, the FDA and Stryker notified healthcare providers of a class I recall of Stryker’s OASYS Midline Occiput Plate.  This most serious type of recall was issued because of reports of fracture of the pin that connects the implant's head to the plate body. According to their website, Stryker is one of the world’s [...]

September 3rd, 2013|Drug and Medical Device Litigation|0 Comments