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Boston Scientific has recalled the RotaWire Elite Guidewire and wireClip Torquer Guidewire components of its Rotablator Rotational Atherectomy System. The company received three reports of wires fracturing, one during preparation of the device, and two during actual surgeries. The fractures during surgery resulted in migration of the wire, puncturing the pericardium surrounding the heart. One patient died during surgery to remove the broken wire.
The Rotabator Rotational Atherectomy System is used to surgically remove atherosclerosis from arteries. The device uses a tiny burr rotating at high speed to remove plaque and improve blood flow to the heart. The tip of the device rotates at 190,000 rotations per minute during the procedure.
The recall covers 955 devices distributed in the following states: Arizona (AZ), California (CA), Delaware (DE), Florida (FL), Georgia (GA), Illinois (IL), Louisiana (LA), Maryland (MD), Mississippi (MI), Minnesota (MN), Nebraska (NE), New York (NY), Pennsylvania (PY), South Carolina (SC), Texas (TX), Washington (WA), and Wisconsin (WI). The recalled devices were manufactured from June 26, 2015 to Sept. 10, 2015 and distributed from July 9, 2015 to Oct. 1, 2015.
Boston Scientific sent hospitals an Urgent Medical Device Recall letter in October of 2015 asking them to stop using the device immediately. The FDA announced the Class 1 recall of the device in November.
If you believe you suffered injuries as a result of a faulty Boston Scientific guidewire, contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.