Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0690-2021)

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:

Five IceRod" i-Thaw" Prostate Cryoablation Kit

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0690-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 178 units

Code Information:

UPN: FPRPR3571 UDIs: 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976 Batch Numbers: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated