Boston Scientific Corp issued a 2015 recall of RotaWire ‘Elite’ core wires used for atheroctomy, which is a procedure that uses a guidewire to remove plaque from a blood vessel.
The recalled Boston Scientific guidewires 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.
The use of the affected product may cause serious adverse health consequences, including death.
Product Information
- RotaWire Elite Guidewire and wireClip Torquer Guidewire;
- Material Numbers: H802223301 (5-pack, outer package UPN) H802223300 (single unit, inner package UPN); H802233301 (5-pack, outer package UPN) H802233300 (single unit, inner package UPN);
- 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.
This product was 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)
- Wisconsin (WI)
Claim for Compensation
You may have a claim for compensation if:
- You underwent an atherectomy procedure that used a Boston Scientific RotaWire Elite Guidewire;
- There is evidence that the guidewire separated during the procedure;
- There is evidence that you were injured as a result of the separation.
If there is evidence your loved one died as a result of the recalled guidewire, you and your family may have a wrongful death claim.
You can contact our law firm using our free consultation form, and talk to a lawyer for free about your case.