Data Foundry

Medical device recalls 2021

Contour VL Variable Length Ureteral Stent Set — Class II medical device recall Z-0758-2021

Ongoing recall by Boston Scientific Corporation, reported 2021-01-06, distributed nationwide. Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was

Recall numberZ-0758-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBoston Scientific Corporation, Marlborough, MA, United States
Recall initiated2020-11-16
Classified2020-12-30
Reported by FDA2021-01-06
DistributedNationwide (US)
Countries outside the USJP
Quantity458 units
UPC / GTIN / UDI-DI08714729423768, 08714729423829, 08714729765837, 08714729772743
Lot numbers25928323, 25928324, 25928325, 25928326, 25933063, 25933064, 25933065, 25965814, 25966020

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0758-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.