Black Silicone G15147Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002151475), received between Oct 6, 2016 and Apr 7, 2026 — classified as 3 injuries, 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Break

  IT HAS BEEN REPORTED THAT PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET, BROKE "COMING OUT OF THE PACKAGE". A NEW STENT WAS OPENED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 24808696 ↗
• MalfunctionJan 12, 2026Break

  AS REPORTED, THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH A 'FILIFORM DOUBLE PIGTAIL URETERAL STENT SET' WAS IMPLANTED IN THE LEFT URETER. DURING STENT REMOVAL BY THE PHYSICIAN, IT BROKE INTO THREE PIECES. ALL PIECES WERE SUBSEQUENTLY REMOVED USING A REUSABLE GRASPER. AN UNSPECIFIED MANUFACTURER'S CYSTOSCOPE AND STENT RETRIEVER WERE USED DURING REMOVAL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 24040511 ↗
• MalfunctionJun 27, 2019Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741424 ↗
• MalfunctionApr 12, 2018Break

  THE COMPLAINANT REPORTED THAT PART OF THE PIGTAIL WAS BROKEN AS THE USER REMOVED THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET FROM THE PACKAGING TRAY. THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426857 ↗
• MalfunctionApr 10, 2018Detachment Of Device Component; Fracture; Out-Of-Box Failure

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PIGTAIL URETERAL STENT WAS FRACTURED AND DETACHED WHEN OPENING THE PACKAGE. IT WAS FURTHER NOTED THE STENT WAS RETURNED IN THREE PIECES.

  Patient problems: No Patient Involvement

  MAUDE report 7413209 ↗
• MalfunctionAug 15, 2017Detachment Of Device Component; Detachment Of Device Component

  THE USER FACILITY REPORTED THE PIGTAIL PART OF THE FILIFORM DOUBLE PIGTAIL URETERAL STENT WAS DETACHED WHEN THE PACKAGE WAS OPENED. THIS DEVICE WAS NOT USED AND THERE WAS NO PATIENT CONTACT. AS REPORTED, THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6793692 ↗
• InjuryMar 24, 2017Difficult To Position; Device Operates Differently Than Expected; Difficult To Position; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A RIGHT URETEROSCOPY WITH STONE EXTRACTION AND STENT PLACEMENT PROCEDURE. THE DEVICE IN USE WAS A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET. THE INITIAL REPORTER INDICATED THAT THE BLACK SILICONE STENT GOT STUCK ON THE SENSOR HYBRID WIRE WHILE THE PHYSICIAN WAS ATTEMPTING TO PUSH THE STENT UP THE URETER. THE ATTENDING PHYSICIAN SWAPPED OUT THE SENSOR FOR A STIFF FIXED CORE COOK WIRE AND THE STENT GOT STUCK AGAIN. THE PHYSICIAN STATED THE ISSUE WAS NOT IDENTIFIED DUE TO THE STENT COULD NOT BE VISUALIZED TO DETERMINE WHERE THE STENT WAS CATCHING AND WAS UNABLE TO BE POSITIONED. INCLUSION, THE PHYSICIAN ENDED THE PROCEDURE AND THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN STATED THERE WAS A PERFORATION THAT MAY HAVE BEEN THERE PRIOR TO THE PROCEDURE OR POSSIBLY FROM MULTIPLE EXPLORATIONS. HE FURTHER STATED THE DEVICE ITSELF DID NOT CONTRIBUTE TO THE PERFORATION. BECAUSE OF THE PERFORATION, THE PATIENT WILL REQUIRE PERCUTANEOUS ACCESS TO RETRIEVE THE STON

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6432797 ↗
• InjuryOct 6, 2016Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT HAD A STENT PLACED IN EARLY (B)(6) 2016. AFTER SEVERAL MONTHS, THE STENT WAS FOUND TO BE SURROUNDED BY CALCULUS; THEREFORE, THE STENT WAS REMOVED IN LATE (B)(6) 2016. DURING THE PROCEDURE, THE NEAR-SIDE STENT WAS REMOVED, BUT THE DISTAL PART FAILED TO REMOVE. THE SURGEON OPERATED USING THE PNEUMATIC LITHOTRIPSY UNDER URETEROSCOPE. THE USER TOOK AN URETEROSCOPY TO TAKE OUT THE DETACHED PART OF THE STENT EVENTUALLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY.

  Patient problems: No Code Available

  MAUDE report 6004287 ↗
• InjuryOct 6, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT HAD A STENT PLACED IN (B)(6) 2015. AFTER SEVERAL MONTHS, THE STENT WAS FOUND TO BE SURROUNDED BY CALCULUS. THUS, THE STENT WAS REMOVED IN LATE (B)(6) 2016. THE PATIENT HAD CYSTOLITH WHEN REVIEWING AFTER THE PROCEDURE. THE SURGEON OPERATED USING THE PNEUMATIC LITHOTRIPSY UNDER URETEROSCOPE. THE STENT DETACHED WHILE REMOVING. THE USER TOOK AN URETEROSCOPY TO TAKE OUT THE DETACHED PART OF THE STENT EVENTUALLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Code Available

  MAUDE report 6003410 ↗