FDA recall Z-0758-2021

Boston Scientific Corporation · Class II · device

Product

Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

Reason for recall

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

Distribution

Distribution US nationwide and Japan.

Key facts

Status
Ongoing
Initiation date
2020-11-16
Report date
2021-01-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0758-2021