Contour™ M006180522180Recalls & reported problems

Boston Scientific Corporation · Ureteral Stent Set · Class 2 · Implant

All models of Contour (14)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729789284), received between May 18, 2021 and May 18, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Material Integrity Problem2
Migration2

Patient problems

Insufficient Information2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMay 18, 2021Material Integrity Problem; Migration; Material Integrity Problem; Migration
NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2021-02326 AND MFR. REPORT # 3005099803-2021-02329). IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE TO HELP PROTECT THE URETER AS THE PATIENT UNDERWENT ABDOMINAL SURGERY ON AN UNKNOWN DATE. THE PATIENT WAS INTUBATED IN THE ICU PRIOR TO PROCEDURE. DURING THE PROCEDURE, TWO CONTOUR URETERAL STENTS WERE IMPLANTED BILATERALLY AND FAILED TO COILED. BOTH STENTS WERE LEFT IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE BOTH BILATERAL CONTOUR URETERAL STENTS SLIPPED OUT OF THE PATIENT AND HAD TO BE RETRIEVED VIA CYSTOSCOPY BY THE PHYSICIAN.
Patient problems: Insufficient Information
MAUDE report 11845272 ↗
InjuryMay 18, 2021Material Integrity Problem; Migration; Material Integrity Problem; Migration
NOTE: THIS REPORT IS TWO OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2021-02326 AND MFR. REPORT # 3005099803-2021-02329). IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE TO HELP PROTECT THE URETER AS THE PATIENT UNDERWENT ABDOMINAL SURGERY ON AN UNKNOWN DATE. THE PATIENT WAS INTUBATED IN THE ICU PRIOR TO PROCEDURE. DURING THE PROCEDURE, TWO CONTOUR URETERAL STENTS WERE IMPLANTED BILATERALLY AND FAILED TO COILED. BOTH STENTS WERE LEFT IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE BOTH BILATERAL CONTOUR URETERAL STENTS SLIPPED OUT OF THE PATIENT AND HAD TO BE RETRIEVED VIA CYSTOSCOPY BY THE PHYSICIAN.
Patient problems: Insufficient Information
MAUDE report 11845136 ↗

Device details

UDI-DI	`08714729789284`
Brand	Contour™
Model	M006180522180
Company	Boston Scientific Corporation
Product code	FAD · STENT, URETERAL
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Apr 25, 2022

Device type (GMDN): Polymeric ureteral stent

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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