Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0662-2021)

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 L 90¿ Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0662-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 261 units

Code Information:

UPN: FPRPR3617 UDIs: 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072 Batch numbers: U1310, U1309, U1306, U1305, X0828, U0727, U0728, U0641, U0640, U0587, U0586, U0585, U0084, A7113, A6977, A6963, A6962, A6681, A6682, A1657, A1522, A1178, A1177

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated