Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
RotaWire Elite and wireClip Torquer Recalled by Boston Scientific Corporation Due to Boston Scientific is recalling its recently released RotaWire...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended. The guidewires are intended for use with the Rotablator Rotational Atherectomy System.
Quantity: 955 single units (191 5-packs)
Why Was This Recalled?
Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.
Where Was This Sold?
This product was distributed to 17 states: AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, WI
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report