Recall Z-1012-2019— Boston Scientific Corporation

Name: FDA recall Z-1012-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-26

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2018-12-26, terminated 2020-04-17. It names one FDA 510(k) clearance: K965147. Product: Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220. Reason: The sterile barrier may contain packaging seal defects..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-12-26
Terminated: 2020-04-17
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K965147 — BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESISBoston Scientific Corp·cleared 1997-06-30

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

Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220

Reason for recall

The sterile barrier may contain packaging seal defects.

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