Boston Scientific Rotawire Guidewire Recall Issued Due to Risk of Heart Damage, Death

Following the death of at least one patient, a recall has been issued for certain Boston Scientific Rotablator Rotational Atherectomy Systems with Guidewires, due to a risk that the wires may crack and separate, potentially causing an obstruction of blood flow to the patient’s heart.

The Boston Scientific Rotawire Guidewire recall was announced by the FDA on November 27, following at least three incident reports that suggest the core wires cracked and separated while inside patient arteries. This can cause blood flow obstructions and migration of wire fragments throughout the body. To date, one death has been reported as a result of the cracking wires and two other incidents required immediate removal surgery.

The recalled RotaWire Elite Guidewire and wireClip Torquer Guidewire components are used with the Rotablator Rotational Atherectomy Systems to open narrowed arteries and improve blood flow to the heart by cutting plaque buildups away from the artery wall. The devices allow physicians to perform a minimally invasive surgery for patients with faster recovery times.

In the reported patient death, the Guidewire cracked during the procedure and required immediate medical intervention to try and remove the fragments. The other two incidents similarly involved cracking wires during surgery and required immediate stenting and emergency heart surgery to prevent further fragment migration.

The potential adverse health consequences that can result from a cracking wire component inside of a patient can be extremely dangerous and result in blood buildups in the sac around the heart decreasing the heart function, heart attacks, migration of fragments that may cause blockages or irritation, and death.

The Rotawire Elite Guidewire and wireClip Torquer Guidewire devices sold with the Rotablator Rotational Atherectomy Systems were manufactured by Boston Scientific Corporation of Washington, D.C. from June 26, 2015 through September 10, 2015 and sold to healthcare professionals in 17 states from July 9, 2015 through October 1, 2015. The FDA reports that roughly 600 units were manufactured and sold on the market to customers in 17 states.

The FDA has classified this as a Class I recall, which means the agency believes that the use of the device poses a reasonable probability of serious adverse health consequences including death.

On October 9, Boston Scientific sent an Urgent Medical Device Recall Removal notice requiring all customers to immediately stop distributing and using the devices and return all affected products listed in the notice back to the manufacturer. Distributors are being instructed to notify customers immediately and any further questions should be directed to Boston Scientific by phone, 1-800-811-3211 or email at maplegrovefieldactioncenter@bsci.com.