Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-2681-2020)

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, Three IceFORCE 2.1 Prostate Cyroablation 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-2681-2020

Event ID: 85815

Reason for Recall:

The needle surface deteriorated due to unexpected electrolysis during procedure.

Status: Terminated

Product Quantity: 71 devices

Code Information:

UPN:FPRPR3608, GTIN: 7290104831065, Batch: A1170, A1583, A1937, A6710, A6744, A6857, A6900, A6913, A6926, A7014, A7027, A7122, T0055, T0144, T0181, T0211, T0212, T0238, T0270, T0816, T0815

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