Medical Device Class I Recall for Boston Scientific’s RotaWire Elite Guidewire and wireClip Torquer Guidewire

FDA Announcement on 2015-11-30

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Boston Scientific RotaWire Elite GuideBoston Scientific Corp is recalling RotaWire ‘Elite’ core wires because they may crack and separate from the rest of the Rotablator Rotational Atheroctomy System and cause serious injury such as tamponade (blood in the sac around the heart causing decreased heart function), myocardial infarction (heart attack), and migration of wire fragments elsewhere in the body.

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 blocking off (occluding) the affected artery, placing stents into the affected artery, and emergency heart surgery.

Device Use

The RotaWire Elite Guidewire and wireClip Torquer Guidewire are components of the Rotablator Rotational Atherectomy System. The device is used to open narrowed arteries and improve blood flow to the heart by cutting plaque from the artery wall (atherectomy).

Rotablator Rotational Atherectomy System Prep

Recalled Device

  • RotaWire Elite Guidewire and wireClip Torquer Guidewire
  • All affected products.
  • Manufacturing Dates: June 26, 2015 to September 10, 2015
  • Distribution Dates: July 9, 2015 to October 1, 2015
  • Devices Recalled in the U.S.: 600 Units in 17 States

The use of affected product may cause serious adverse health consequences, including death.

Source: FDA

Last Updated: 2015-11-30

Class I Recall for RotaWire Elite Core Wires Due to Risks of Death or Serious Injury
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