Z-0557-2020Class II

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700

Name: Z-0557-2020 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
Creator: Boston Scientific Corporation
Published: 2019-10-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-10-21 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700 on 2019-10-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0557-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-21
Posted: 2019-11-25
Terminated: 2023-12-20
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Boston Scientific issued Notifications to consignees via Federal Express Priority mail on October 21, 2019. The notification instructs the account to check their inventory remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.
Quantity in commerce: 271 units
Distribution: Nationwide Foreign: Austria Australia Belgium Bulgaria Croatia Czech Rep Denmark Finland France Germany Great Britain Italy Japan Pakistan Poland Russian Fed. Slovakia South Africa Spain Sweden Switzerland Thailand Turkey
Product codes and lots: Lot Numbers: 21483842 21512596 21724129 21806787 21973221 22307744 22460195 23073639 23492663 24271829

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0557-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0548-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0549-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0550-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0551-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0552-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0553-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0554-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0555-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0556-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0557-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0558-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0559-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0560-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25

Product code FGE

K133700Class IIAdvanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and PushersBoston Scientific Corporation / cleared 2014-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)