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SOF-CURL SSC7026Recalls & reported problems

Gyrus ACMI, LLC · 7.0 Fr. (2.3mm) x 26cm SOF-CURL URETERAL STENT · 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 00821925031753), received between Mar 10, 2023 and Mar 10, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Corroded” (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.

Most reported problems

Device problems

  • Corroded1
  • Degraded1
  • Device Contamination with Body Fluid1
  • Peeled/Delaminated1
  • Sharp Edges1

Patient problems

  • Urinary Tract Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 10, 2023Corroded; Degraded; Peeled/Delaminated; Device Contamination with Body Fluid; Sharp Edges; Corroded; Degraded; Peeled/Delaminated; Device Contamination with Body Fluid; Sharp Edges

    ADDITIONAL INFORMATION REGARDING THE PROCEDURE INDICATED THAT THE FOLLOWING PROCEDURES WERE PERFORMED: CYSTOSCOPY, LEFT RETROGRADE URETEROPYELOGRAM, LEFT URETEROSCOPY, BALLOON DILATION AND INSERTION OF A LEFT URETERAL STENT. A QUESTIONABLE OBSTRUCTION WAS NOTED PRE-PROCEDURE. DURING THE PROCEDURE, THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS. THE PROSTATE WAS NOTED TO HAVE OBSTRUCTING MEDIAL LOBES IN THE PROSTATE. NO FOREIGN BODIES WERE NOTED IN THE BLADDER. DURING THE RETROGRADE URETEROPYELOGRAM, THE PATIENT WAS NOTED TO HAVE A SEVERELY TORTUOUS DILATED URETER TO THE LEVEL OF THE DISTAL URETER AND BLADDER. A WIRE WAS INSERTED TO ADVANCE INTO THE LEFT RENAL COLLECTING SYSTEM. THE CYSTOSCOPE WAS REMOVED AND A SEMI RIGID URETEROSCOPE WAS INSERTED AND ADVANCED TO THE DISTAL URETER. SOME MUCUSAL EDEMA WAS NOTED BUT NO FOREIGN BODIES OR STONES WERE NOTED. THE SCOPE WAS ADVANCED TO MIDURETER, AND THE URETER WAS FOUND TO BE DILATED. URINE WAS COLLECTED AND SENT FOR CULTURE. AS THE AREA WAS EDEMATOUS, BALLOON DILATATION WAS DONE OF THAT AREA. THE URETERAL STENT WAS THEN PLACED WITH THE PROXIMAL CURL HE LEFT RENAL PELVIS AND THE DISTAL CURL IN THE BLADDER. THE PATIENT WAS TAKEN TO THE RECO

    Patient problems: Urinary Tract Infection

    MAUDE report 16527185 ↗

Other Stent, Ureteral devices

All Stent, Ureteral devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.