Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0676-2021)

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" 1.5 Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0676-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 152 units

Code Information:

UPN: FPRPR3201 UDIs: 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181 Batch Numbers: U0181, T0393, A6912, A6664, A1915, A1072, A1024, A0853, A0574

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated