Black Silicone G15146Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00827002151468), received between Nov 17, 2014 and Sep 15, 2026 — classified as 9 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778409 ↗
• MalfunctionAug 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132724 ↗
• MalfunctionMay 13, 2026Break

  AS REPORTED, DURING A TRANSURETHRAL URETERAL STENT PLACEMENT FOR IDIOPATHIC HYDRONEPHROSIS, THE STENT OF THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET BECAME ENTANGLED WITH THE GUIDEWIRE, PREVENTING ITS REMOVAL AFTER PLACEMENT. ULTIMATELY, BOTH THE STENT AND GUIDEWIRE WERE WITHDRAWN TOGETHER. WHILE SEPARATING THE STENT FROM THE GUIDEWIRE, SOME STENT FRAGMENTS DETACHED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164192 ↗
• MalfunctionMay 7, 2026Break

  IT HAS BEEN REPORTED THAT THE DISTAL END OF THE STENT INCLUDED IN THE 'FILIFORM DOUBLE PIGTAIL URETERAL STENT SET' WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT AS THE BROKEN DEVICE WAS DISCOVERED AT A DISTRIBUTION CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110412 ↗
• MalfunctionApr 30, 2026Difficult to Advance

  IT WAS REPORTED PRIOR TO A PROCEDURE INVOLVING THE URETER, TWO FILIFORM DOUBLE PIGTAIL URETERAL STENT SET'S WIRES GOT STUCK IN THE STENTS AND COULD NOT BE PULLED OUT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047187 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET BROKE PRIOR TO USE DURING A TRANSURETHRAL URETEROSCOPIC STONE FRAGMENTATION AND REMOVAL PROCEDURE AND URETERAL STENT IMPLANTATION. AFTER STONE CRUSHING AND EXTRACTION, THE STENT WAS PREPPED FOR PLACEMENT BY ROUTINE EXAMINATION AND STRETCHING OF THE STENT OUTSIDE THE BODY. THE STRETCHING PROCESS OF THE STENT INVOLVED STRAIGHTENING THE TWO ENDS OF THE PIGTAIL, WHILE THE USER PLANNED TO PLACE THE STENT ALONG THE WIRE GUIDE. HOWEVER, THE STENT BROKE DURING THIS PROCESS AND WAS REPLACED WITH ANOTHER STENT TO COMPLETE THE PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809157 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET¿S STENT BROKE PRIOR TO USE AN UNSPECIFIED URETER PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24424639 ↗
• MalfunctionFeb 19, 2026Unsealed Device Packaging

  IT WAS REPORTED, THE STERILIZATION PACKAGE OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WAS NOT SEALED COMPLETELY AND LEAKS. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388279 ↗
• MalfunctionFeb 5, 2026Difficult to Advance

  IT WAS REPORTED THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET¿S STENT WAS DIFFICULT TO ADVANCE OVER THE WIRE GUIDE DURING AN UNSPECIFIED PROCEDURE. AS A TEMPORARY MEASURE, A STENT FROM ANOTHER BRAND WAS IMPLANTED. SUBSEQUENTLY, THE SURGERY WAS RESCHEDULED WITH THE PATIENT, AND ANOTHER FILIFORM DOUBLE PIGTAIL URETERAL STENT WAS SUCCESSFULLY IMPLANTED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271183 ↗
• MalfunctionJan 28, 2026Difficult to Advance

  IT WAS REPORTED, DURING A FLEXIBLE URETEROSCOPY, WHEN ATTEMPTING TO PLACE THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET INTO THE KIDNEY, THE STENT WOULD NOT SLIDE OVER THE GUIDEWIRE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198363 ↗
• MalfunctionJan 27, 2026Difficult to Advance

  AS REPORTED, DURING A FLEXIBLE URETEROSCOPY, THE PHYSICIAN REPORTED DIFFICULTLY WHEN ATTEMPTING TO ADVANCE THE 'FILIFORM DOUBLE PIGTAIL URETERAL STENT' OVER THE GUIDEWIRE AND INTO THE KIDNEY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188870 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WAS FOUND TO BE BROKEN WHEN THE USER OPENED THE PACKAGE AND REMOVED THE DEVICE PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A NEW UNSPECIFIED STENT. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094597 ↗
• MalfunctionJan 15, 2026Difficult to Advance

  IT WAS REPORTED THAT THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WAS DIFFICULT TO ADVANCE OVER THE WIRE GUIDE. PRIOR TO PATIENT INSERTION DURING A DOUBLE J STENT PLACEMENT PROCEDURE IN THE URETER, THE STENT COULD NOT BE ADVANCED OVER THE WIRE GUIDE DURING DEPLOYMENT. THE USER USED AN ALTERNATIVE SILICONE STENT TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24089010 ↗
• MalfunctionDec 12, 2025Break; Break

  AS REPORTED, PRIOR TO AN UNSPECIFIED PROCEDURE, ONE PIGTAIL END OF THE STENT INCLUDED IN THE 'FILIFORM DOUBLE PIGTAIL URETERAL STENT' WAS FOUND TO BE BROKEN. THE ISSUE WAS DISCOVERED BY THE PHYSICIAN DURING THE PRE-OPERATIVE EXAMINATION UPON OPENING THE PACKAGING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER NEW STENT. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794613 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET, THE USER FOUND THE STENT TO BE BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER UNSPECIFIED STENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014767 ↗
• MalfunctionAug 25, 2025Break; Break

  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 22891885 ↗
• MalfunctionAug 11, 2025Break; Break

  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 22773259 ↗
• MalfunctionAug 6, 2025Difficult to Advance; Difficult to Advance

  AS REPORTED, DURING RETROGRADE INTRARENAL SURGERY (RIRS), THE WIRE GUIDE COULD NOT BE PUSHED INTO THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET. A NEW SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. 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 22731103 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET¿S STENT WAS BROKEN PRIOR TO USE IN THE URETEROLITHOTOMY PROCEDURE. THE ISSUE WAS FOUND WHEN THE NURSE OPENED THE PACKAGE AND CHECKED THE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED BY USING SAME-TYPE DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396188 ↗
• MalfunctionJun 9, 2025Break; Break

  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 22168113 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED, PRIOR TO PATIENT CONTACT FOR A TRANSURETHRAL VESICOURETERAL STENT IMPLANTATION PROCEDURE, THE DOCTOR OPENED THE PACKAGE OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET AND FOUND THE STENT BROKEN AND THEN REPLACED WITH A NEW STENT TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134555 ↗
• MalfunctionMay 1, 2025Break; Break

  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 21942416 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED, THE USER OPENED THE PACKAGE OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET AND FOUND THE STENT WAS BROKEN/DISCONNECTED. THE STENT WAS GOING TO BE USED FOR A URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY FOR STONE EXTRACTION. THE USE OF THE DEVICE WAS DISCONTINUED. THE USER CHANGED TO ANOTHER SAME TYPE OF DEVICE TO COMPLETE THE PROCEDURE. AN IMAGE WAS PROVIDED SHOWING THE STENT SEPARATED. 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 21595181 ↗
• MalfunctionMar 12, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THE 6FR SILICON DJ STENT FROM A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WAS NOT EASILY GOING OVER GUIDEWIRE WHEREAS A 6FR POLYURETHANE DJ STENT WENT EASILY, DESPITE THERE BEING NO INSTRUMENTAL ERRORS DURING THE PROCEDURE WHICH WAS ABANDONED. THE POLYURETHANE STENT WAS PLACED IN THE SAME PROCEDURE. THE STENT AS INDICATED DUE TO PROSTATE CARCINOMA WITH OBSTRUCTIVE UROPATHY. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586373 ↗
• MalfunctionJan 7, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557239 ↗