Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0665-2021)

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 i-Thaw" Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0665-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 262 units

Code Information:

UPN: FPRPR4009 UDIs: 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204 Batch Numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated