Black Silicone G15145Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002151451), received between Jun 8, 2017 and Apr 3, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING A RETROGRADE INTRARENAL SURGERY, THE WIRE COULD NOT BE PUSHED INTO THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET. THE PROCEDURE WAS COMPLETED BY USING A NEW FILIFORM DOUBLE PIGTAIL URETERAL STENT SET. 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 24778136 ↗
• MalfunctionFeb 19, 2026Difficult to Advance

  IT WAS REPORTED, DURING RIGHT RETROGRADE PYELOGRAM (RPG) AND STENT INSERTION, THE STENT FROM A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WOULD NOT ADVANCE OVER THE GUIDEWIRE. THE FAILURE TO GLIDE OVER GUIDEWIRE CAUSED THE STENT TO "CONCERTINA" AND PREVENT ANY FURTHER ADVANCEMENT INTO THE BLADDER FROM THE RIGID SCOPE. A COOK COMPETITORS' STENT 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 24388553 ↗
• MalfunctionSep 11, 2025Break; Break

  AS REPORTED, UPON OPENING THE PACKAGE OF THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET, IT WAS DISCOVERED THAT ONE SIDE OF THE TIP WAS BROKEN. THE BREAK WAS FOUND PRIOR TO AN URETEROSCOPY AND LASER STONE FRAGMENTATION (URSL) PROCEDURE AND DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER-SAME LIKE DEVICE. A CUSTOMER PROVIDED PHOTO APPEARS TO SHOW A CURL OF THE STENT IS MISSING, AND THE TETHER IS ABSENT. 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 23031165 ↗
• MalfunctionAug 20, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED DURING A GYNECOLOGICAL PROCEDURE THE DOCTOR COULD NOT GET THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET TO DEPLOY. USED ANOTHER STENT FROM A COMPETITOR 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 22853907 ↗
• MalfunctionMay 9, 2025Difficult to Advance; Difficult to Advance

  DURING A STONE REMOVAL PROCEDURE, THE STENTS FROM TWO FILIFORM DOUBLE PIGTAIL URETERAL STENT SETS WERE UNABLE TO ADVANCE OVER THE WIREGUIDE. THE PROCEDURE WAS COMPLETED BY USING A UNIVERSA SOFT STENT. THE TWO STENTS THAT WERE UNABLE TO ADVANCE OVER THE WIREGUIDE HAD DIFFERENT LOT NUMBERS. REFERENCE PATIENT IDENTIFIER: (B)(6) (THIS REPORT) FOR STENT # 2, AND REFERENCE PATIENT IDENTIFIER: (B)(6) FOR THE STENT # 1. A THIRD STENT WAS ATTEMPTED TO BE USED; HOWEVER, THE SURGEON MISTAKENLY USED A STENT THAT WAS TOO SHORT, THEN REMOVED IT. THE PROCEDURE WAS COMPLETE BY USING A 4TH STENT WHICH WAS A UNIVERSA SOFT STENT. AS SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. NO PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996632 ↗
• MalfunctionMay 9, 2025Difficult to Advance; Difficult to Advance

  DURING A STONE REMOVAL PROCEDURE, THE STENTS FROM TWO FILIFORM DOUBLE PIGTAIL URETERAL STENT SETS WERE UNABLE TO ADVANCE OVER THE WIREGUIDE. THE PROCEDURE WAS COMPLETED BY USING A UNIVERSA SOFT STENT. THE TWO STENTS THAT WERE UNABLE TO ADVANCE OVER THE WIREGUIDE HAD DIFFERENT LOT NUMBERS. REFERENCE PATIENT IDENTIFIER (B)(6) (THIS REPORT) FOR STENT # 1, AND REFERENCE PATIENT IDENTIFIER (B)(6) FOR THE STENT # 2. A THIRD STENT WAS ATTEMPTED TO BE USED, HOWEVER, THE SURGEON MISTAKENLY USED A STENT THAT WAS TOO SHORT, THEN REMOVED IT. THE PROCEDURE WAS COMPLETE BY USING A 4TH STENT WHICH WAS A UNIVERSA SOFT STENT. AS SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. NO PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996498 ↗
• MalfunctionApr 3, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET¿S STENT WAS TOO SOFT. THE PHYSICIAN HAD DIFFICULTY INSERTING IT DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER BRAND OF DEVICE. 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 21763734 ↗
• MalfunctionApr 10, 2019Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500704 ↗
• MalfunctionSep 11, 2018Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7864212 ↗
• MalfunctionApr 12, 2018Break

  THE COMPLAINANT REPORTED THAT THE FILIFORM DOUBLE PIGTAIL URETERAL STENT BROKE UPON INSERTION DURING A CARDIOVASCULAR PROCEDURE. THERE WERE NO REPORTS OF ANY SECTIONS OF THE DEVICE REMAINING WITHIN THE PATIENT OR ANY SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426595 ↗
• MalfunctionMar 20, 2018Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  IT WAS REPORTED THE PHYSICIAN PLANNED TO REPLACE THE PATIENT¿S URETERAL STENT. WHEN OPENING THE PACKAGE CONTAINING THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET, THE USER FOUND ONE END OF THE STENT WAS BROKEN. FURTHER CLARIFICATION WAS RECEIVED ADVISING THAT THE STENT WAS CRACKED BUT IT WAS STILL TOGETHER. THE STENT WAS NOT USED. A NEW STENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE WAS NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7354880 ↗
• MalfunctionJun 8, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT AFTER AN INTENDED URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE, THE PHYSICIAN TRIED TO PUT FILIFORM DOUBLE PIGTAIL URETERAL STENT SET ON THE RIGHT SIDE KIDNEY AND FOUND THAT THE PIGTAIL OF THE STENT SET WAS CUT OFF. THEREFORE, THE PHYSICIAN REMOVED THE STENT FROM THE KIDNEY. THE PHYSICIAN COMPLETED THE PROCEDURE USING UNIVERSAL SOFT URETERAL STENT SET. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6622265 ↗