Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0687-2021)

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:

IceSeed" Prostate Cryoablation Kit

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0687-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 52 units

Code Information:

UPN: FPRPR3008 UDIs: 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068 Batch Numbers: T0783, T0686, T0719, T0678, A6713, A6676, A2130, A2075, A1813, A1695, A1684

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated