Device product
Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Z-2682-2020
Product summary
- Event
- Event 85815
- Status
- Terminated
- Classification
- Class II
- Quantity
- 205 devices
- Official record key
device-enforcement:Z-2682-2020
Official wording
Reason: The needle surface deteriorated due to unexpected electrolysis during procedure.
Code information: UPN: FPRPR3617, GTIN: 07290104831072 , Batch: A0904, A1085, A1177, A1178, A6681, A6682, A6962, A6963, A6977, A7113, U0084
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
The needle surface deteriorated due to unexpected electrolysis during procedure.