Recall Z-0550-2020— Boston Scientific Corporation

Name: FDA recall Z-0550-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-21

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2019-10-21, terminated 2023-12-20. It names one FDA 510(k) clearance: K133700. Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630. Reason: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-10-21
Terminated: 2023-12-20
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K133700 — ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERSBoston Scientific Corporation·cleared 2014-05-14

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

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630

Reason for recall

Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

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