Stretch™ VL M006185156010Recalls & reported problems
Boston Scientific Corporation · Variable Length Flexima™ Stent Set · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729160816), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Calcified” (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
- Calcified1
- Difficult to Remove1
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.
InjuryJun 27, 2023Calcified; Difficult to Remove; Calcified; Difficult to Remove
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STRETCH VL URETERAL STENT WAS USED DURING A URETEROSCOPIC LITHOTRIPSY WITH CYSTOSCOPE PROCEDURE IN THE URETER ON (B)(6) 2023. DURING ROUTINE FOLLOW-UP, A PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2023. DURING THIS PROCEDURE, THE PHYSICIAN FOUND ENCRUSTATION ON THE STENT, AND THE STENT COULD NOT BE REMOVED WITH A CYSTOSCOPE. THE PHYSICIAN HAD TO USE A LASER FOR STONE REMOVAL AND TO BREAK UP THE ENCRUSTATION ON THE STENT IN ORDER FOR THE STENT TO BE REMOVED. THE PROCEDURE WAS COMPLETED, AND THE STENT WAS SUCCESSFULLY REMOVED. ANOTHER STENT WAS NOT PLACED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A MEDIA OF THE COMPLAINT DEVICE WAS PROVIDED SHOWING THE CALCIFIED STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17211206 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- 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
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
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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