Stretch™ VL M006185155180Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729777250), received between May 4, 2017 and May 4, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STRETCH¿ VL URETERAL STENT WAS USED IN THE URETER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS PLACED, FORCEPS WERE USED TO ADJUST THE POSITION BY PULLING ON THE STENT. HOWEVER, THE STENT COIL DETACHED FROM THE STENT WHILE INSIDE THE PATIENT. FORCEPS WERE THEN USED TO REMOVE THE DETACHED PIECE OF STRETCH¿ VL URETERAL STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STRETCH¿ VL URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6546632 ↗
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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