Boston Scientific Corporation recalls MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision,…

Recall date

March 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1798-2020

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Worldwide distribution - US Nationwide and Global distribution.

Why it was recalled

To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.