Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0681-2021)

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:

IceSeed" 1.5 MRI Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0681-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 627 units

Code Information:

UPN: FPRPR3192 UDIs: 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266 Batch Numbers: U1438, U1439, U0962, U0961, U0437, U0378, T0697, T0688, T0388, T0387, A7150, A7149, A2018, A2017, A1711, A1710, A1689, A1403, A1404, A0896, A0897

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated