Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0661-2021)

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:

IcePearl" 2.1 CX Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0661-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 86 units

Code Information:

UPN: FPRPR3603 UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010 Batch Numbers: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated