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.
- 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 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).
Reason for Recall
Boston 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.
The use of affected product may cause serious adverse health consequences, including death.
Who may be affected
Patients who undergo atherectomy procedures.
What to Do
Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter to customers beginning October 9, 2015.
The letter listed the following instructions:
- Stop distributing and using these devices immediately.
- Return all affected products to Boston Scientific following the recall instructions in the letter.
- Distributors should notify any customer who may have received the product.
- Return the Recall Removal Reply Verification Tracking Form to Boston Scientific via email: email@example.com, or fax: 1-866-213-1806.
Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to Boston Scientific by calling 1-800-811-3211.
Date Recall Initiated
October 9, 2015
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
Full List of Affected Devices
|Product Description||Material Number (UPN)||Batch||Batch Expiration Date|
|RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation Device||H802223301 (5-pack, outer package UPN) H802223300 (single unit, inner package UPN)||18201519|
|6/25/2017 through 9/9/2017|
|H802233301 (5-pack, outer package UPN) H802233300 (single unit, inner package UPN)||18141187|
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)