Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0658-2021)

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:

IceFORCE" 2.1 CX Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0658-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 75 units

Code Information:

UPN: FPRPR3604 UDIs: 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027 Batch Numbers: U0903, U0785, U0617, U0042, T0166, T0156, A7083, A6931, A6928, A6916, A6734, A1549, A1527, X1483, A1203

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated