Sof-Flex G15696Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002156968), received between Apr 12, 2018 and Oct 21, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THAT THE 'STRINGS' DETACHED FROM THE 'SOF-FLEX MULTI-LENGTH URETERAL STENT' DURING ATTEMPTED PATIENT SELF-REMOVAL. THE STENT WAS IMPLANTED ON (B)(6) 2024, DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE, AND THE PATIENT ATTEMPTED TO REMOVE THE STENT, AS INSTRUCTED, ON (B)(6) 2024. THE PATIENT RETURNED TO THE CLINICAL SETTING ON (B)(6) 2024 AND RETAINED STENT WAS CONFIRMED VIA IMAGING. THE STENT WAS THEN REMOVED WITH A FLEXIBLE CYSTOSCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494800 ↗
• InjuryOct 21, 2024Break; Break

  IT WAS REPORTED THAT THE 'STRINGS' DETACHED FROM THE 'SOF-FLEX MULTI-LENGTH URETERAL STENT' DURING ATTEMPTED PATIENT SELF-REMOVAL. THE STENT WAS IMPLANTED ON (B)(6) 2024, DURING A RIGHT FLEXIBLE URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE, AND THE PATIENT ATTEMPTED TO REMOVE THE STENT, AS INSTRUCTED, ON 02JUL2024 . DURING ATTEMPTED REMOVAL, THE 'STRINGS' SEPARATED FROM THE DEVICE AND THE STENT REMAINED IN THE PATIENT. THE PATIENT RETURNED TO THE CLINICAL SETTING ON (B)(6) 2024 AND RETAINED STENT WAS CONFIRMED VIA IMAGING. THE USER ATTEMPTED TO REMOVE THE STENT WITH A FLEXIBLE CYSTOSCOPE BUT WAS UNSUCCESSFUL. THE STENT IS SCHEDULED TO BE RETRIEVED UNDER A GENERAL ANESTHESIA (GA) ON (B)(6) 2024; NO INFORMATION HAS SINCE BEEN MADE AVAILABLE REGARDING THE SCHEDULED STENT REMOVAL. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 20494664 ↗
• MalfunctionApr 12, 2018Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, WHEN AN USER REMOVED THE URETERAL STENT FROM THE STERILE PACKAGING AND PULLED OFF THE SUTURE, THE TOP OF THE STENT PIGTAIL PULLED OFF. IT WAS FURTHER NOTED THAT PROXIMAL STENT COIL WAS RIPPED AND SEVERED AT THE SIDEPORT. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426923 ↗