Sof-FlexRecalls & reported problems across all models
Cook Incorporated · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 14 models of Sof-Flex by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between May 16, 2017 and May 22, 2026 — classified as 7 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Break” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Sof-Flex problems
Device problems
- Break7
- Device Damaged Prior to Use4
- Material Separation3
- Material Split, Cut or Torn3
- Calcified2
- Device Contaminated During Manufacture or Shipping2
- Crack1
- Insufficient Device Problem Information1
Patient problems
- No Consequences Or Impact To Patient9
- No Clinical Signs, Symptoms or Conditions7
- Foreign Body In Patient4
- No Known Impact Or Consequence To Patient2
- Pain2
- Unspecified Kidney or Urinary Problem2
- Urolithiasis2
- Bacterial Infection1
Sof-Flex models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sof-Flex G14840STENT, URETERAL5 reports
- Sof-Flex G15696STENT, URETERAL3 reports
- Sof-Flex G14867STENT, URETERAL2 reports
- Sof-Flex G14898STENT, URETERAL2 reports
- Sof-Flex G14906STENT, URETERAL2 reports
- Sof-Flex G15608STENT, URETERAL2 reports
- Sof-Flex G15942CATHETER, UROLOGICAL2 reports
- Sof-Flex G17852STENT, URETERAL2 reports
- Sof-Flex G14783STENT, URETERAL1 report
- Sof-Flex G14866STENT, URETERAL1 report
- Sof-Flex G15003STENT, URETERAL1 report
- Sof-Flex G15397STENT, URETERAL1 report
- Sof-Flex G15944CATHETER, UROLOGICAL1 report
- Sof-Flex G16035STENT, URETERAL1 report
Recent Sof-Flex adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionFeb 11, 2025Break; Break
AS REPORTED, THE USER OF A SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET FOUND THE STENT WAS SEPARATED IN TWO PIECES IN THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED ON THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21360866 ↗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 ↗InjuryOct 7, 2024Material Separation; Material Separation
AS REPORTED, A 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET' WAS PLACED ON (B)(6) 2024 FOR A STENT RE-IMPLANT PROCEDURE AND FRACTURED AT THE PATIENTS HOME ON (B)(6) 2024. THE PATIENT REPORTED TO HAVE PAIN AND PASSED PART OF THE STENT AT HOME; THE PATIENT THEN RETURNED TO THE USER FACILITY FOR REMOVAL OF THE REMAINING STENT FRAGMENTS REMOVED FROM THE URETHRA AND BLADDER. ANOTHER STENT WAS NOT PLACED. THE STENT WAS NOT SET TO BE REMOVED FOR ANOTHER 2 WEE KS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY OTHER ADDITIONAL INTERVENTION OR EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Foreign Body In Patient; Pain
MAUDE report 20385678 ↗InjurySep 30, 2024Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device
IT WAS REPORTED THAT A 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT' WAS PLACED ON (B)(6) 2024 FOR TREATMENT OF A PELVIC TUMOR AND HYDRONEPHROSIS. THE PATIENT WAS DISCHARGED HOME BUT RETURNED ON (B)(6) 2024 DUE TO THE STENT PROTRUDING FROM URETHRAL MEATUS. THE PATIENT RETURNED TO THE OPERATING ROOM WHERE IT WAS NOTED THAT THE DEVICE HAD SEPARATED; THE SURGEON USED A URETEROSCOPE TO CHECK FOR ANY REMAINING STENT FRAGMENTS IN THE URETHRA AND KIDNEY. IT WAS REPORTED THAT THE REMAINING PIECES OF THE STENT WERE REMOVED. A REPLACEMENT STENT WAS PLACED AND THE PATIENT WAS HOSPITALIZED FOR AN ADDITIONAL DAY. THE DEVICE DID NOT PERFORATE ANY PART OF THE PATIENT'S ANATOMY.
Patient problems: Foreign Body In Patient
MAUDE report 20334071 ↗MalfunctionOct 1, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849354 ↗MalfunctionAug 18, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED 28AUG2023. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17577195 ↗MalfunctionNov 17, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ADDITIONAL INFORMATION WAS RECEIVED 23NOV2022. THE ISSUE WAS DISCOVERED AS THE DEVICE WAS DELIVERED TO THE USER FACILITY. THE DEVICE WAS NOT INVOLVED IN ANY PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15813349 ↗MalfunctionJun 28, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, WHEN A SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET WAS OPENED, THEY NOTICED THAT ONE OF THE PIGTAILS HAD A SLIT IN THE MATERIAL. THE DEVICE WAS NOT USED ON THE PATIENT. THE TETHER WAS ATTACHED WHEN THE PACKAGE WAS OPENED, BUT THE TECH CUT THE TETHER OFF WITH SCISSORS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED. NO ADVERSE EVENTS WERE REPORTED DUE TO THE OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14841448 ↗InjuryFeb 10, 2022Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 13505283 ↗MalfunctionOct 13, 2021Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12625388 ↗InjuryJul 30, 2020Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10343225 ↗MalfunctionJun 26, 2020Packaging Problem; Packaging Problem
ADDITIONAL INFORMATION WAS RECEIVED 04AUG2020: THE HAIR IN THE PACKAGE WAS DISCOVERED WHEN THE DEVICE WAS RECEIVED AT OUR DISTRIBUTORS WAREHOUSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10200169 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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