Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0671-2021)

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:

IceSphere" 1.5 Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0671-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 245 units

Code Information:

UPN: FPRPR3558 UDIs: 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938 Batch numbers: U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, A1185

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated