FDA recall Z-1798-2020

Boston Scientific Corporation · Class II · device

Product

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.

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide and Global distribution.

Key facts

Status
Terminated
Initiation date
2020-03-30
Report date
2020-05-06
Termination date
2023-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1798-2020