Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-2679-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Ablation Galil Technology, IcePearl¿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.

Product Classification:

Class II

Date Initiated: June 4, 2020

Date Posted: July 29, 2020

Recall Number: Z-2679-2020

Event ID: 85815

Reason for Recall:

The needle surface deteriorated due to unexpected electrolysis during procedure.

Status: Terminated

Product Quantity: 193 devices

Code Information:

UPN:FPRPR3606, GTIN: 7290104831041, Batch: A1148, A1171, A1248, A1460, A1561, A1582, A1936, A2121, A6702, A6743, A6856, A6925, A7013, A7026, A7088, A7148, T0054, T0136, T0141, T0224, T0236, T0237, T0268, T0437, T0592, U0082, U0027, U0093, U0226, U0227

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.

Voluntary or Mandated:

Voluntary: Firm initiated