NA M0061802010Recalls & reported problems

Boston Scientific Corporation · Ureteral Stent Positioner · Class 1

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729751472), received between Feb 2, 2021 and Feb 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

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

Appropriate Device Problem Term/Code Not Available1
Defective Device1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 2, 2021Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A URETERAL STENT POSITIONER WAS OPEN TO BE USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN UNPACKED THE PACKAGE, IT WAS NOTICED THAT THE STENT POSITIONER WAS BROKEN. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11269937 ↗

Device details

UDI-DI	`08714729751472`
Brand	NA
Model	M0061802010
Company	Boston Scientific Corporation
Product code	KOA · SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Urological catheter stylet, transurethral

A sterile, metal wire or flexible rod, typically with a plastic knob at the proximal end, intended to be inserted into the lumen of a urological catheter or cannula (not included) to increase stiffness sufficiently to facilitate manipulation/introduction into the urethra or ureter (via the urethra); it is not intended to assist introduction of a percutaneous catheter. It is available in various lengths, diameters, and degrees of rigidity. This is a single-use device.

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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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