Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0672-2021)

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:

IceSphere" 1.5 S 90¿ Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0672-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 729 units

Code Information:

UPN: FPRPR3561 UDIs: 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556 Batch Numbers: U1176, U1175, U0460, U0459, U0157, T0702, T0389, T0390, T0371, T0370, T0064, T0065, T0045, T0044, A7075, A7074, A6873, A6872, A1632, A1633, A1616, A1615, A1363, A1364

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated