Bard® TigerTail™ Flexible Tip Ureteral Catheters 139005Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10801741127097), received between Nov 16, 2020 and Mar 20, 2026 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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, 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL CATHETERS SOFT TIP WAS DISLODGED IN PATIENT'S KIDNEY DURING RETROGRADE PYELOGRAM ON (B)(6) 2026. DEVICE BREAKAGE WENT UNDETECTED AT CONCLUSION OF SURGERY. FOREIGN BODY WAS IDENTIFIED ON SUBSEQUENT IMAGING FOR PATIENT. DOCTOR ATTEMPTED TO RETRIEVE FOREIGN BODY WHILE COMPLETING PERCUTANEOUS NEPHROLITHOTOMY AND THE FOREIGN BODY WAS PUSHED INTO BLADDER. ON (B)(6) 2026 PATIENT RETURNED TO OPERATING ROOM FOR RETRIEVAL OF FOREIGN BODY AND FULGURATION OF BLEEDING. DOCTOR RETRIEVED FOREIGN BODY AND SENT TO PATHOLOGY. VISUAL IDENTIFICATION INDICATED FOREIGN BODY WAS LIKELY SOFT TIP OF THE URETERAL CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 24649419 ↗
• InjuryAug 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED A FAILURE IN THE BARD POLYURETHANE URETERAL CATHETER REF # 139005RT FLEXIBLE TIP 5 FR X 70CM LOT # REKN1298 EXP 02/28/2029 ON 7/27/25. THIS CATHETER TIP ABOUT 2 CM LONG BROKE DURING SURGERY BUT WAS RETRIEVED DURING THE CASE WITH NO ADVERSE EFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22883284 ↗
• MalfunctionJun 24, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT BEFORE USE, URETERAL CATHETER WAS CRUSHED FROM THE BEGINNING, MAKING IT DIFFICULT FOR THE GUIDEWIRE TO PASS THROUGH. THE GUIDEWIRE COULD NOT PASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320052 ↗
• MalfunctionAug 13, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT TIGERTAIL URETERAL CATHETER TAILS KINKED OUT OF THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972858 ↗
• MalfunctionJun 17, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT BEFORE USE, DOCTOR COULD NOT PASS A WIRE THROUGH THE URETERAL CATHETER DUE TO THE CATHETER KINKED OR HAS A NARROWING AT PROXIMAL END. THEY OPENED A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547217 ↗
• MalfunctionJun 10, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING USE, DOCTOR WANTED TO PASS A WIRE THROUGH THE URETERAL CATHETER BUT FOUND IT DIFFICULT TO PASS, NOTICED THERE WAS A KINK OR NARROWING AT PROXIMAL END OF CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497487 ↗
• MalfunctionApr 26, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DOCTOR NEEDED A TIGER TAIL URETERAL CATHETER TO PERFORM A RETROGRADE STUDY, NOTICED THE CATHETER HAD A KINK AND COULD NOT USE. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 12APR2024, AS PER CUSTOMER DEVICE WAS PLACED INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192659 ↗
• MalfunctionMar 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER HAD 2 BARD 5FR OPEN ENDED CATHETERS WHICH HAD RIP ACROSS THE PLASTIC THEREFORE CONTAMINATING THE SUPPLY. THE LOT NUMBER ON BOTH WAS REHV4176.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912955 ↗
• MalfunctionJan 2, 2024Accessory Incompatible; Difficult to Advance; Accessory Incompatible; Difficult to Advance

  IT WAS REPORTED THAT THE CUSTOMER PLACED GUIDEWIRE AND WAS NOT GOING THROUGH ON TWO. PER FOLLOW UP ON 06FEB2024, IT WAS REPORTED THAT THE PATIENT WAS NOT HURT OR INJURED. THE PHYSICAL PRODUCT WAS NOT AVAILABLE FOR SAMPLE RETURN. IT WAS DISCARDED AFTER USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426248 ↗
• MalfunctionNov 21, 2023Accessory Incompatible; Deformation Due to Compressive Stress; Accessory Incompatible; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROXIMAL PORTION OF URETERAL CATHETER WAS KINKED DUE TO HUB BEING TOO TIGHT AND SUBSEQUENTLY MAKING IT DIFFICULT TO PASS A GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183267 ↗
• MalfunctionNov 21, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DOCTOR HAD ISSUES SINCE THEY SWITCHED IT OVER FROM COOK TO BARD. THE TOP OF TIGERTAIL WAS PUT ON ENTIRELY TOO TIGHT, CAUSED IT TO KINK, THE DOCTOR CANNOT PUT A WIRE OR LASER FIBER THROUGH WITHOUT CUTTING TIGERTAIL AND USING IT LIKE THAT. THIS HAS HAPPENED NOW WITH EVERY TIGERTAIL THEY PULLED 4 TO 5 TIMES. NEEDED TO CUT TIGERTAIL IN ORDER TO USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181169 ↗
• MalfunctionAug 17, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE TIGERTAIL URETERAL CATHETER WAS CURLING, AND WAS NOT ALLOWING THE GUIDEWIRE TO PASS THROUGH IT (BATCH # REGX3459). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17MAR2023, STATED THAT AN ADDITIONAL BATCH# ALSO HAD THE SAME ISSUE (BATCH # REGW2678). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23MAR2023, STATED THAT THEY WERE NOT SURE WHETHER SOME OF THE DEVICE CAME INTO CONTACT WITH A PATIENT. CERTAINLY MANY WERE OPENED AND THEN DETERMINED TO BE DEFECTIVE WHEN GUIDE WIRE WAS NOT ABLE TO PASS THE CRIMP. THERE WAS NO PATIENT HARM NOTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26JUL2023, STATED THAT THE DEVICE WAS USED IN PATIENTS. THE EVALUATION AND FINAL CONCLUSION WAS NOT BASED ON EVIDENCE AND PROBLEM ENCOUNTERED. THE URETERAL CATHETER AS IT CAME OUT THE PACKAGE WAS NOT ADEQUATE OR USEABLE. THE CATHETER END UNDER THE CLEAR PART OR UNDER THE WHITE PART OF THE ADAPTOR WAS ALREADY CRUMPLED. THE ADAPTOR ACTUALLY WAS LOOSENED, NOT TIGHTENED (BATCH # REGX3459 AND BATCH # REGW2678). THEREFORE IT WAS NOT ALLOWING ANYTHING TO PASS, INCLUDING A WIRE, THROUGH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563693 ↗
• MalfunctionAug 14, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CONNECTOR OF THE URETERAL CATHETER DID NOT LOCK EVEN WHEN TURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540865 ↗
• MalfunctionMay 5, 2023Nonstandard Device; Fitting Problem; Nonstandard Device; Fitting Problem

  IT WAS REPORTED THAT THE GUIDEWIRE WAS TOO SNUG IN THE LUMEN OF A TIGERTAIL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875535 ↗
• MalfunctionApr 18, 2023Material Too Rigid or Stiff; Device Handling Problem; Material Too Rigid or Stiff; Device Handling Problem

  IT WAS REPORTED BY THE CUSTOMER THAT SINCE ABOUT A MONTH AGO, WHENEVER PATIENT USED THE RED TIP (RIGHT), THE LUMEN WAS STIFF THAT THE GUIDE WIRE DID NOT GO UP WELL. BLUE TIP (LEFT) WAS WELL THOUGH IT WERE IN SAME BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761204 ↗
• MalfunctionApr 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIGERTAIL URETERAL CATHETER WAS CURLING, AND WAS NOT ALLOWING THE GUIDEWIRE TO PASS THROUGH IT (BATCH # REGX3459). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17MAR2023, STATED THAT THE AN ADDITIONAL BATCH# ALSO HAD THE SAME ISSUE (BATCH # REGW2678). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23MAR2023, STATED THAT THEY WERE NOT SURE WHETHER SOME OF THE DEVICE CAME INTO CONTACT WITH A PATIENT. CERTAINLY MANY WERE OPENED AND THEN DETERMINED TO BE DEFECTIVE WHEN GUIDE WIRE WAS NOT ABLE TO PASS THE CRIMP. THERE WAS NO PATIENT HARM NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700781 ↗
• MalfunctionApr 3, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIGERTAIL URETERAL CATHETER WAS CURLING, AND WAS NOT ALLOWING THE GUIDEWIRE TO PASS THROUGH IT (BATCH # REGX3459). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17MAR2023, STATED THAT THE AN ADDITIONAL BATCH# ALSO HAD THE SAME ISSUE (BATCH # REGW2678). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23MAR2023, STATED THAT THEY WERE NOT SURE WHETHER SOME OF THE DEVICE CAME INTO CONTACT WITH A PATIENT. CERTAINLY MANY WERE OPENED AND THEN DETERMINED TO BE DEFECTIVE WHEN GUIDE WIRE WAS NOT ABLE TO PASS THE CRIMP. THERE WAS NO PATIENT HARM NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662757 ↗
• MalfunctionFeb 24, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE RED AND BLUE CAPS WERE SCREWED ON TOO TIGHTLY ON TIGER TAIL CATHETERS AND DID NOT ALLOW FOR GUIDEWIRE TO BE PASSED THROUGH BECAUSE THE CAP WAS SCREWED SO TIGHTLY AND IT COMPRESSES THE CATHETER. THE SURGEON HAD TO CUT OF THE AREA WHERE THE CAP WAS SCREWED ON, SO THEY COULD PASS A GUIDEWIRE THROUGH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436518 ↗
• MalfunctionFeb 3, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE WIDTH WAS NOT CONSISTENT THROUGHOUT THE TIGER TAIL CATHETER AND THE WIRE GOT STUCK AND THE STAFF HAD TO CUT THE CATHETER TO REMOVE IT. THERE WAS NO PATIENT HARM, AND THE PHYSICIAN FEELS THIS WAS NOT THE FIRST TIME HE HAS HAD THIS OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16295419 ↗
• MalfunctionJan 31, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE OPEN ENDED CATHETER (TIGERTAIL CATHETER) FELL OFF FROM THE CATHETER DURING THE PROCEDURE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16272031 ↗
• MalfunctionNov 7, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS A PINCH NEAR THE NON MARKED END IN FEW OF THE POLYURETHANE URETERAL CATHETERS THAT MADE IT HARD TO PASS A WIRE. PER FOLLOW-UP VIA EMAIL ON 04NOV2022, IT WAS REPORTED THAT THEY OPENED TWO TIGER TAILS THAT WERE LIKE THIS. THE THIRD ONE WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15745879 ↗
• MalfunctionJun 6, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT 10 X TIGER TAIL CATHETERS WERE KINKED AND BENT ON THE PACKAGE. IT WAS MENTIONED AS SINCE THE PRODUCTS BEING POORLY PACKED, THE USER WAS NOT WILING TO USE IT TO RISK THE PROCEDURE OR PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601991 ↗
• MalfunctionJun 6, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT 10 X TIGERTAIL CATHETERS WERE KINKED AND BENT ON THE PACKAGE. IT WAS MENTIONED AS SINCE THE PRODUCTS BEING POORLY PACKED, THE USER WAS NOT WILING TO USE IT TO RISK THE PROCEDURE OR PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601842 ↗
• MalfunctionApr 28, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CUSTOMER REPORTED ADDITIONAL ISSUES WITH THE TIGERTAIL TIP URETERAL CATHETERS, FOR WHICH THE LOT# WERE UNKNOWN. PER FOLLOW UP INFORMATION RECEIVED ON 12APR2022, THE URETERAL CATHETERS HAVING THE SYRINGE CONNECTOR SCREWED ON SO TIGHT THAT IT WAS DAMAGING THE CATHETERS AND WAS NOT ALLOWING THE WIRE TO PASS THROUGH THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240674 ↗
• MalfunctionFeb 1, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE TIGERTAIL URETERAL CATHETERS HAD THE SYRINGE CONNECTOR SCREWED ON SO TIGHT THAT IT WAS DAMAGING THE CATHETERS AND NOT ALLOWING THE WIRE TO PASS THROUGH THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415452 ↗