SOF-CURL 5626024Recalls & reported problems
Gyrus ACMI, LLC · SOF-CURL Ureteral Stent 6.0 FR X 24 cm w/PTFE Coated Extra Firm Guidewire 3 cm Flexible Tip .038" X 150 cm · Class 2 · Implant
- 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 00821925005631), received between Nov 21, 2023 and Nov 21, 2023 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Migration1
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.
InjuryNov 21, 2023Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
THE CUSTOMER REPORTED THAT THE SOF-CURL URETERAL STENT 6.0X24 COULD NOT BE FOUND AT ITS INTENDED PLACE AS CONFIRMED THROUGH X-RAY AND THAT THE CURLS WERE IN THE RENAL PELVIS. A CYSTOSCOPE WAS USED TO INVESTIGATE, AND THE REST OF THE STENT WAS FOUND IN THE BLADDER. IT WAS NOTED THAT THE STENT HAD DETACHED BETWEEN WHEN IT WAS INITIALLY PLACED ON 10/11/23 UNTIL 11/01/23 WHEN IT WAS DISCOVERED VIA X-RAY. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18186991 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.