Black SiliconeRecalls & reported problems across all models

We found 10 models of Black Silicone by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 84 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2014 and Sep 15, 2026 — classified as 1 death, 13 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Break” (34 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

Most reported Black Silicone problems

Black Silicone models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Black Silicone G15146

  STENT, URETERAL
  51 reports
• Black Silicone G15145

  STENT, URETERAL
  12 reports
• Black Silicone G15147

  STENT, URETERAL
  9 reports
• Black Silicone G15124

  STENT, URETERAL
  4 reports
• Black Silicone G15120

  STENT, URETERAL
  2 reports
• Black Silicone G15144

  STENT, URETERAL
  1 death2 reports
• Black Silicone G15123

  STENT, URETERAL
  1 report
• Black Silicone G15127

  STENT, URETERAL
  1 report
• Black Silicone G15128

  STENT, URETERAL
  1 report
• Black Silicone G15130

  STENT, URETERAL
  1 report

Recent Black Silicone adverse event reports

The 15 most recent reports across all models, 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 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50140666 ↗
• 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 ULTIMATELY, BOTH THE STENT AND GUIDEWIRE WERE WITHDRAWN TOGETHER.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 ↗
• 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 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT PRIOR TO A URETER PROCEDURE, UPON OPENING THE PACKAGE, A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET'S STENT WAS FOUND BROKEN NEAR THE END OF THE PIGTAIL. THE STENT WAS REPLACED WITH A NEW SAME-LIKE DEVICE 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 24794096 ↗
• 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 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, 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 ↗
• 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 29, 2026Break

  IT WAS REPORTED THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WAS FRACTURED PRIOR TO AN UNKNOWN PROCEDURE IN THE URETER. UPON OPENING THE PACKAGING, THE PIGTAIL END OF THE UPPER SEGMENT OF THE STENT WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED BY USING A REPLACEMENT 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 24215590 ↗

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