Percuflex™ Plus M0061752610Recalls & reported problems

Boston Scientific Corporation · Ureteral Stent · Class 2 · Implant

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 08714729067795), received between Apr 12, 2024 and Apr 12, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Contaminated During Manufacture or Shipping1

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.

MalfunctionApr 12, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS OPENED TO BE USED ON (B)(6) 2024. DURING PREPARATION, A HAIR WAS FOUND INSIDE THE STERILE PACKAGING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT A FOREIGN MATTER WAS INSIDE THE STERILE PACKAGING. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102343 ↗

Device details

UDI-DI	`08714729067795`
Brand	Percuflex™ Plus
Model	M0061752610
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	MR Safe
Status	In Commercial Distribution
Record updated	Jan 19, 2026

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.

Other STENT, URETERAL devices

Bard® InLay Optima® Ureteral Stent 788426
C. R. Bard, Inc. · STENT, URETERAL
1 recall100 reports
Bard® InLay Optima® Ureteral Stent 788626
C. R. Bard, Inc. · STENT, URETERAL
122 reports
Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626
C. R. Bard, Inc. · STENT, URETERAL
118 reports
Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426
C. R. Bard, Inc. · STENT, URETERAL
108 reports
Bard® InLay® Ureteral Stent 778626
C. R. Bard, Inc. · STENT, URETERAL
100 reports
Percuflex™ Plus M0061752530
Boston Scientific Corporation · STENT, URETERAL
1 death99 reports
Contour VL™ M0061801560
Boston Scientific Corporation · STENT, URETERAL
1 recall45 reports
Polaris™ Ultra M0061921330
Boston Scientific Corporation · STENT, URETERAL
71 reports

All STENT, URETERAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.