Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0673-2021)

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 90¿ Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0673-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 92 units

Code Information:

UPN: FPRPR3260 UDIs: 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259 Batch Numbers: U0326, U0325, U0286, U0285, A7012, A7011

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated