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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86880

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 16, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

Z-0757-2021
Recall number
Z-0757-2021
Initiated
November 16, 2020
Classification
Class II
Status
Ongoing
Quantity
458 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 08714729058410: Lots 25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 25753933, 25790349. GTIN 08714729067986: Lots 25640715, 25670518, 25686790, 25686791, 25686792, 25741763, 25741770, 25753937, 25790351, 25795704, 25802759, 25809481, 25822104. GTIN 08714729068020: Lots 25578740, 25583824.

Distribution pattern

Distribution US nationwide and Japan.

device · product 2 of 2

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

Z-0758-2021
Recall number
Z-0758-2021
Initiated
November 16, 2020
Classification
Class II
Status
Ongoing
Quantity
458 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020.

Distribution pattern

Distribution US nationwide and Japan.