Sof-Flex G14867Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002148673), received between May 22, 2026 and May 22, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Calcified” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Calcified

  AS REPORTED, THE 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT' CONTAINED DEPOSITS/CALCIFICATIONS. URETHRAL STENT PLACEMENT WAS FOLLOWING KIDNEY TRANSPLANT. THE STENT WAS IMPLANTED ON (B)(6) 2025 AND REMOVED ON (B)(6) 2025. UPON REMOVAL, THE UROLOGIST NOTED THE STENT WAS COVERED IN DEBRIS, WITH DEPOSITS ANCHORED TO THE DEVICE. THE SURGEON SUBMITTED THE DEVICE TO PATHOLOGY FOR IDENTIFICATION OF THE STONE/DEPOSIT MATERIAL. ULTRASOUND FINDINGS NOTED THE URETERIC STENT IN SITU WITH ASSOCIATED UROTHELIAL THICKENING, AS WELL AS A LEFT LOWER QUADRANT DRAIN IN SITU. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Unspecified Kidney or Urinary Problem; Urolithiasis

  MAUDE report 25256495 ↗
• InjuryMay 22, 2026Calcified

  AS REPORTED, THE 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT' CONTAINED DEPOSITS/CALCIFICATIONS. THE URETERAL STENT PLACEMENT WAS FOLLOWING KIDNEY TRANSPLANT. THE STENT WAS PLACED ON (B)(6) 2026 AND REMOVED ON (B)(6) 2026. ULTRASOUND IMAGING DEMONSTRATED INCREASED URETERAL WALL THICKENING. FOLLOWING DEVICE REMOVAL, DEPOSITS/ENCRUSTATION WERE NOTED ON BOTH ENDS OF THE STENT (SEE ATTACHED IMAGE). POST-REMOVAL ULTRASOUNDS CONTINUED TO DEMONSTRATE MILD HYDRONEPHROSIS WITH INTERVAL WORSENING COMPARED TO PRIOR IMAGING, PERSISTENT URETERAL DILATION THROUGHOUT ITS COURSE MEASURING UP TO 9 MM, AND INTERVAL REMOVAL OF THE URETERAL STENT. IMAGING ALSO IDENTIFIED A 6.7 MM NON-MOBILE ECHOGENIC FOCUS WITHIN THE DISTAL URETER DEMONSTRATING TWINKLE ARTIFACT ON COLOR DOPPLER EXAMINATION. THE ECHOGENIC FOCUS APPEARED EMBEDDED WITHIN THE URETERAL WALL AND SURROUNDED BY A HETEROGENEOUS AREA, SUGGESTIVE OF A SMALL CALCULUS WITH SURROUNDING GRANULATION TISSUE. FOLLOWING STENT REMOVAL, THE UROLOGIST NOTED THE STENT TO BE MORE HEAVILY ENCRUSTED THAN EXPECTED. THE DEPOSITS/CALCULUS MATERIAL WERE SUBMITTED FOR STONE ANALYSIS ON A STAT BASIS, WITH RESULTS PENDING AS OF (B)(6) 2026. THE PATIENT SUBSEQUE

  Patient problems: Hydronephrosis; Sepsis; Unspecified Kidney or Urinary Problem; Urinary Tract Infection; Urolithiasis

  MAUDE report 25255869 ↗