FDA Device recall Z-0758-2021
Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
- 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 Set, UPN M006180155090, M006180156090, M006180156180, M006180156190 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-0758-2021 |
| 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 Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
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 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064,…GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020. |
|---|
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-0758-2021%22
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