Flexima™ M001274020Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent System · Class 2
- 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 08714729323778), received between Dec 15, 2023 and Sep 15, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Difficult or Delayed Positioning1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Difficult or Delayed Positioning; Deformation Due to Compressive Stress
It was reported that the stent was buckled, resulting in subsequent device explant.A Flexima? device was selected for use in a left antegrade ureteric stenting procedure. The patient was numbed using local anesthesia. During the procedure, the stent was able to be implanted with difficulty, but was shown to have buckled, and was protruding from the nephrostomy site. The physician performed multiple retrieval attempts with a snare to reposition the stent , but was ultimately unsuccessful. The index procedure was cancelled. On August 04, 2026, the patient underwent an additional procedure to retrieve the stent and implant a new stent. There were no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774539 ↗InjuryDec 15, 2023Material Separation; Material Separation
IT WAS REPORTED THAT THE SUTURE REMAINED IN THE PATIENT. A FLEXIMA URETERAL STENT SYSTEM WAS INSERTED FOR DRAINAGE OF THE URETER. DURING REMOVAL OF THE DEVICE, AT THE END OF THE PROCEDURE, THE LOCKING SUTURE COULD NOT BE REMOVED. THE SUTURE WAS CUT AT THE STRING ENTRY POINT AND REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 18334429 ↗
Other STENT, URETERAL devices
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- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
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- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.