Recall Z-1798-2020— Boston Scientific Corporation

Name: FDA recall Z-1798-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-30

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-03-30, terminated 2023-04-05. It names one FDA 510(k) clearance: K120870. 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: 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-03-30
Terminated: 2023-04-05
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K120870 — GREENLIGHT MOXY FIBER OPTICAmerican Medical Systems·cleared 2012-06-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.