FDA recall Z-2674-2020

Boston Scientific Corporation · Class II · device

Product

Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

Reason for recall

The needle surface deteriorated due to unexpected electrolysis during procedure.

Distribution

Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.

Key facts

Status
Terminated
Initiation date
2020-06-04
Report date
2020-07-29
Termination date
2024-09-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2674-2020