Recall Z-2958-2020— Boston Scientific Corporation

Name: FDA recall Z-2958-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-07

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-08-07, terminated 2020-12-23. It names one FDA 510(k) clearance: K140630. Product: 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.. Reason: Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-08-07
Terminated: 2020-12-23
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K140630 — WALLFLEX BILIARY RX STENT SYSTEMBoston Scientific·cleared 2014-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.