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Recall Observatory FDA recall evidence

Device product

Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

Z-2678-2020

June 04, 2020

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 85815
Status
Terminated
Classification
Class II
Quantity
79 devices
Official record key
device-enforcement:Z-2678-2020

Official wording

Reason: The needle surface deteriorated due to unexpected electrolysis during procedure.

Code information: UPN: FPRPR3605, GTIN: 7290104831034, Batch: A1105, A1193, A1291, A1435, A1550, A1565, A1776, A1781, A6758, A6930, A7062, A7061, T0153

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The needle surface deteriorated due to unexpected electrolysis during procedure.