FDA Device recall Z-0757-2021
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
- FDA Device
- Class II
- ongoing
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570 by Boston Scientific, citing trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0757-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-16 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Reason
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
Identifiers
| code_info | GTIN 08714729058410: Lots 25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 2575393…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0757-2021%22
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