FDA recall Z-0106-2022

Intuitive Surgical, Inc. · Class II · device

Product

Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

Reason for recall

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

Distribution

US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China

Key facts

Status
Terminated
Initiation date
2021-08-06
Report date
2021-10-20
Termination date
2024-05-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0106-2022