Z-0758-2021Class II

Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

Name: Z-0758-2021 Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Creator: Boston Scientific Corporation
Published: 2020-11-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-11-16 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190 on 2020-11-16. FDA classified it as Class II and gives the reason as "Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0758-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-16
Posted: 2020-12-30
Recalling firm: Boston Scientific Corporation
Product: Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Product code: FAD Stent, Ureteral
Reason for recall: Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions: - Verify whether you have any product from the affected lots/batches within your inventory - Immediately cease use or distribution of any remaining unused product from the affected lots/batches - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. - Distributors should forward the notification to their customers Your local Sales Representative can answer any questions that you may have regarding this notification.
Quantity in commerce: 458 units
Distribution: Distribution US nationwide and Japan.
Product codes and lots: GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0758-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0757-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-06	2020-12-30
Z-0758-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-06	2020-12-30

Product code FAD

K974541Class IIModified Ureteral Indwelling Catheter/stentBoston Scientific Corp / cleared 1998-02-09

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)