Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0668-2021)

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:

IceRod" 1.5 90¿ Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0668-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 93 units

Code Information:

UPN: FPRPR3204 UDIs: 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242 Batch Numbers: U0495, U0498, U0496, U0497, U0420, A0902, A0903

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated