Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0689-2021)

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 IceSphere" Prostate Cryoablation Kit

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0689-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 419 units

Code Information:

UPN: FPRPR3570 UDIs: 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969 Batch Numbers: U1402, U1223, U1224, U1225, U1177, U1178, U1118, U1115, U1070, U1069, U0824, U0825, U0823, U0826, U0470, U0411, U0402, U0407, U0384, U0389, U0216, U0183, U0122, U0154, U0155, T0673, T0672, T0635, T0484, T0483, T0461, T0462, T0373, T0374, T0363, T0362, T0127, T0104, T0103, A7009, A6953, A6952, A6890, A6789, A6737, A2101, A2088, A1629, A1626, A1607, A1577, A1382, A1184

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated