Stent, Ureteral
Boston Scientific Corporation's record for this product code
Recent MDR events
1,553 adverse event reports on file
- Polaris? UltraJul 31, 2026Malfunction2124215-2026-41291
- Polaris? LoopJul 29, 2026Malfunction2124215-2026-40523
- ContourJul 28, 2026Malfunction2124215-2026-40215
- PERCUFLEXJul 22, 2026Injury2124215-2026-39490
- PERCUFLEX PLUSJul 22, 2026Malfunction2124215-2026-39570
- PERCUFLEX PLUSJul 21, 2026Malfunction2124215-2026-38786
- POLARIS? ULTRAJul 21, 2026Malfunction2124215-2026-39042
- POLARIS? LOOPJul 21, 2026Malfunction2124215-2026-39047
- PERCUFLEX PLUSJul 17, 2026Malfunction2124215-2026-38431
- PERCUFLEXJul 13, 2026Malfunction2124215-2026-37424
Recalls
4 recall events for this product code
- TerminatedMay 21, 2009
Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.
View FDA record ↗ - TerminatedMay 21, 2009
Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.
View FDA record ↗ - Open, ClassifiedUnknown
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
View FDA record ↗ - Open, ClassifiedUnknown
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
View FDA record ↗
510(k) clearances
7 clearances for this product code
- K250824Apr 15, 2025
Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
- K211934Nov 10, 2022
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
- K200260Apr 26, 2021
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
- K191446Jan 2, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
- K191609Aug 16, 2019
Tria Soft Ureteral Stent
- K190603May 24, 2019
Tria Firm Ureteral Stent
- K163399Jun 22, 2017
Tria Firm Ureteral Stent