Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0683-2021)

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:

IcePearl" 2.1 CX Prostate Cryoablation Kit

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0683-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 215 units

Code Information:

UPN: FPRPR3606 UDIs: 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041 Batch Numbers: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated