Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0667-2021)

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 PLUS Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0667-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 255 units

Code Information:

UPN: FPRPR3510 UDIs: 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570 Batch Numbers: U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, A1531

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated