Sof-Flex G15608Recalls & reported problems
Cook Incorporated · Sof-Flex Double Pigtail Ureteral Stent Set · Class 2 · Implant
All models of Sof-Flex (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002156081), received between Nov 7, 2018 and Apr 1, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Material Frayed1
Patient problems
- Bacterial Infection1
- Fever1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2019Material Frayed; Material Frayed
THERE IS NO NEW EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8471143 ↗InjuryNov 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED, A RIGHT OPEN PYELOPLASTY (KIDNEY) OPERATION WAS PERFORMED (B)(6) 2018. AS ROUTINE PART OF THE OPERATION, 3(B)(4) , 12 CM SOF-FLEX PEDIATRIC DOUBLE PIGTAIL STENT WAS INSERTED DURING THE OPERATION (OPEN INSERTION DIRECTLY INTO URETER ANTEGRADE DURING THE PELVIURETERAL NEO ANASTOMOSIS). THE WAS AN UNEVENTFUL SURGERY. ROUTINE INTRAOPERATIVE URINE CULTURE TAKEN SHOWED NO BACTERIAL GROWTH. AS REPORTED, PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2018. PATIENT RETURNED AND WAS READMITTED THE NEXT DAY (B)(6) 2018 WITH FEVER. SEPTIC WORKUP CONFIRMED PSEUDOMONAS URINARY TRACT INFECTION. PATIENT IS STILL HOSPITALISED UNDERGOING INTRAVENOUS ANTIBIOTIC TREATMENT FOR URINARY TRACT INFECTION. PLAN IS TO COMPLETE 2 WEEKS THERAPEUTIC ANTIBIOTICS (1 WEEK OF INTRAVENOUS GENTAMICIN WITH POSSIBILITY OF CONVERTING TO 1 WEEK MORE OF ORAL CIPROFLOXACIN TOMORROW). USUALLY THE DJ STENT WILL BE REMOVED 8 WEEKS AFTER OPERATION, HOWEVER, THERE IS A POSSIBILITY WE MAY NEED TO REMOVE IT EARLIER THAN THAT IF WE ARE UNABLE TO CLEAR PSEUDOMONAS COLONISATION OF STENT. THIS WILL INCREASE THE RISK OF RECURRENT PUJO COMPLICATION. THE FOLLOWING ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE DESCRI
Patient problems: Bacterial Infection; Fever
MAUDE report 8046325 ↗
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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