Z-2958-2020Class II

WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 -

Name: Z-2958-2020 WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 -
Creator: Boston Scientific Corporation
Published: 2020-08-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-08-07 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of... on 2020-08-07. FDA classified it as Class II and gives the reason as "Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2958-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-07
Posted: 2020-09-12
Terminated: 2020-12-23
Recalling firm: Boston Scientific Corporation
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.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required on July 31, 2020, via BSC Sales Representatives. The Sales Representatives contacted accounts to determine whether or not the affected inventory had been used. If the product was not used at the site, the product was quarantined. Additionally, customer notification letters to the 32 consignees were sent via Federal Express Priority Overnight mail on July 31st, 2020. Letter states reason for recall, health risk and action to take: Your local Boston Scientific sales representative is available to support this removal. 1. Immediately segregate the affected product to ensure that it will not be used. 2. Contact the Boston Scientific Field Action center for an RGA number to facilitate product return. 3. Ship product back to Boston Scientific We recommend clinical re-evaluation of patients implanted with an uncovered stent from this lot to determine if stent removal is appropriate. 1. Immediately discontinue use of and segregate affected product. 2. Complete the enclosed Reply Verification Tracking Form. 3. Indicate on your Verification Form the quantity of units that you will be returning. 4. Email or fax the Reply Verification Tracking Form to the BSC Field Action Center as described Email: [email protected] or Fax to: Field Action Center 1-866-213-1806. Please email or fax your Reply Verification Tracking Form(s) immediately. Replacement devices will be issued for all product returning to Boston Scientific.
Quantity in commerce: 40 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot code:25607019 Exp. Date: June 17th , 2022 GIN:08714729953180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2958-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2958-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11

Product code FGE

K140630Class IIWallflex Biliary Rx Stent SystemBoston Scientific / cleared 2014-05-23

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)