FDA: Class 1 Recall for Boston Scientific’s RotaWire Elite, WireClip Torquer Guidewires

Boston Scientific’s Rotawire Elite core wires may crack and separate from the rest of the Rotablator Atherectomy System, FDA’s MedWatch program warned physicians on Friday. The FDA alert stems from a Class 1 Recall issued by the company November 13, 2015, for the Rotawire Elite and the WireClip Torquer.

Both the RotaWire Elite Guidewire and WireClip Torquer Guidewire are components of the Rotablator Rotational Atherectomy System.

Boston Scientific sent letters to healthcare providers marked “Urgent Medical Device Recall Removal” and “Immediate Action Required” on October 9, 2015, the FDA recall notes. Affected by the recall are 600 units manufactured between June 26 and September 10, 2015, and distributed between July 9 and October 1, 2015, in 17 US states.

The recall comes following 3 reports of problems with the devices, including 1 patient who died following an intervention to retrieve the broken wire. Broken or detached wires can cause death or serious injuries including tamponade, MI, and migration of wire fragments elsewhere in the body, the FDA alert stated.

In the October 9, 2015, letter, Boston Scientific advise physicians to stop distributing and using the devices, effective immediately, and to return products to the company.

Source:
Food and Drug Administration. RotaWire Elite Guidewire and WireClip Torquer Guidewire by Boston Scientific: Recall - Wires May Break and Separate from the Rotablator System: FDA safety communication. 
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm474632.htm.  Published on: November 27, 2015. Accessed on: November 27, 2015.