Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-2677-2020)

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, IceFORCE 2.1 CX Needle Cryoablation Needle, 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-2677-2020
Event ID: 85815
Reason for Recall:

The needle surface deteriorated due to unexpected electrolysis during procedure.

Status: Terminated
Product Quantity: 39 devices
Code Information:

UPN: FPRPR3604, GTIN: 7290104831027, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041 A1203, A1549, A6734, A6916, A6928, A6931, A7083, T0156, T0166, U0042

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