Boston Scientific has issued a recall for the RotaWire Elite Guidewire and wireClip Torquer Guidewire.
It has been discovered that these guidewires may crack and separate from the Rotablator rotational atheroctomy system and cause serious injury, such as tamponade, myocardial infarction and migration of wire fragments.
The company has received three reports of this issue occurring, including one patient death following medical intervention to remove the broken wire. Other interventions have included purposefully occluding the affected artery, placing stents into the affected artery, and emergency heart surgery.
The use of affected product may cause serious adverse health consequences, including death.