Stretch™ VL M006185157080Recalls & reported problems
Boston Scientific Corporation · Flexima™ Ureteral 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729297765), received between Nov 7, 2024 and Nov 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Material Deformation1
- Material Split, Cut or Torn1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2024Difficult to Remove; Material Deformation; Material Split, Cut or Torn; Difficult to Remove; Material Deformation; Material Split, Cut or Torn
IT WAS REPORTED THAT, AROUND (B)(6) 2024, DURING TRANSURETHRAL LITHOTRIPSY PROCEDURE A STRETCH VL URETERAL STENT WAS USED. UPON UNPACKING, A KINK BETWEEN THE STENT COILS WAS OBSERVED; HOWEVER, THE STENT WAS SUCCESSFULLY PLACED FROM THE RENAL PELVIS INTO THE BLADDER. ON (B)(6) 2024, AN ATTEMPT WAS MADE TO REMOVE THE STENT, BUT A KNOT HAD FORMED AT THE TIP AND DEVELOPED STITCHES ON THE RENAL PELVIS AND WAS DIFFICULT TO REMOVE. ANOTHER REMOVAL ATTEMPT WAS MADE, AND IT WAS SUCCESSFULLY REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20631349 ↗
Other TUBE, DRAINAGE, SUPRAPUBIC devices
- Flexima™ APDL M001271380Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC17 reports
- Flexima™ APDL M001271340Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC2 deaths16 reports
- Flexima™ APDL M001271960Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC1 death10 reports
- Flexima™ APDL M001271350Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC9 reports
- Flexima™ APD™ M001271360Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC8 reports
- Flexima™ APDL M001271330Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC6 reports
- Flexima™ APDL M001275010Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC3 reports
- Flexima™ APDL M001275030Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC3 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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