Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-2958-2020)

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:

WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.

Product Classification:

Class II

Date Initiated: August 7, 2020

Date Posted: September 23, 2020

Recall Number: Z-2958-2020

Event ID: 86226

Reason for Recall:

Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device

Status: Terminated

Product Quantity: 40 units

Code Information:

Lot code:25607019 Exp. Date: June 17th , 2022 GIN:08714729953180

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated