Palindrome 8888541023PRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521158504), received between Jun 15, 2017 and Sep 2, 2025 — classified as 1 death, 5 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (10 reports).

49 other recalls cover devices cleared under the same FDA submission (K123196); they may or may not involve this specific model.

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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Material Puncture/Hole; Device Markings/Labelling Problem; Material Puncture/Hole; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, A RUPTURE OCCURRED IN THE Y-NEAR SILICONE TUBE SEGMENT OF THE VENOUS LEGS OF THE CATHETER. THE CATHETER HAD BEEN NEWLY PLACED IN THE LEFT INTERNAL JUGULAR VEIN. IT WAS STATED THAT THE PRODUCT SHOULD NO LONGER BE USED, AS IT AGED TOO QUICKLY AND THEN CAUSED DANGEROUS PROBLEMS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22936915 ↗
• InjuryAug 19, 2021Misconnection; Misconnection

  ACCORDING TO THE REPORTER, 30 MINUTES INTO THE DIALYSIS TREATMENT, THE VENOUS BLOOD TUBE GOT DISCONNECTED FROM THE VENOUS LIMB OF THE CATHETER. THE PATIENT HAD A BLOOD LOSS AND THE ADAPTERS WERE TIGHTEN BY HANDS. IT WAS ALSO STATED THAT RESUSCITATION AND BLOOD TRANSFUSION (CIRCA 1.200ML BLOOD/EK`S) WERE PERFORMED TO RESOLVE THE ISSUE AND AS THE MEDICAL INTERVENTION DONE TO THE PATIENT. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2021 AND WAS STILL THERE. THE TREATMENT WAS NOT PROCEEDED, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS PERFORMED WITH SALINE 0.9% AND NORMAL RESULT WAS NOTED. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, THERE WAS NO DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED, THE BLOOD OF THE PATIENT WAS NOT RETURNED (THE BLOOD THAT RAN ON THE BED AND FLOOR) AND THERE WAS NO DAMAGE/DEFECT TO THE CATHETER ITSELF. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, OCTENISEPT NON-ALCOHOLIC (ALCOHOL FREE) WAS USED AS THE CLEANING AGENT ON THE DEVICE PRIOR TO USE AND TO CLEAN THE ADAPTERS. THE PATIENT WAS NOW STABLE, CAN WALK AND SPEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340917 ↗
• MalfunctionJun 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE EVENING AFTER THE CATHETER INSTALLATION, THE PATIENT WHO WAS SUFFERING FROM DEMENTIA HAD A DISPUTE WITH ANOTHER PATIENT IN WHICH THE Y-PIECE CAME OFF THE CATHETER. THE NURSE REMOVED THE SUTURE AND SNAP CONNECTOR, SECURED THE CATHETER SHAFT WITH A CLAMP AND EVERYTHING WAS COVERED STERILE. THE NEXT DAY, THE PATIENT CAME TO THE HOSPITAL TO CONTROL (FOR REPAIR) WITH THE CLAMPED CATHETER SHAFT AND STAYED OVER NIGHT IN THE HOSPITAL'S NEPHROLOGY DEPARTMENT. THE PHYSICIANS IMMEDIATELY SAW THE LOST SNAP CONNECTOR AND HUB WHICH WAS SAID TO BE LOST ON THE EVENING OF DATE OF IMPLANTATION. IT WAS SAID THAT THE PHYSICIANS COULD NOT SEE IF IT WAS CUT OR ONLY LOST. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. STERILE NACL (SODIUM CHLORIDE) WAS USED AS CLEANING AGENT ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH CODAN COLOURED PRIOR TO PRODUCT PLACEMENT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. FLUSHING WITH STERILE NACL WAS DONE PRIOR TO CATHETER INSERTION WITH A NORMAL FUNCTION RESULT. THERE WAS A MINIMAL BLOOD LOSS BUT NO BLOOD TRANSFUSION WAS REQUIRED. IT WAS SAID THAT THESE PHYSICIANS CLAMPED THE CATHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037903 ↗
• MalfunctionApr 21, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE PATIENT'S HEMODIALYSIS SESSION, THE ARTERIAL LINE OF THE CATHETER WAS SUCKING IN AIR WHICH WAS CAUSING AIR BUBBLES. THE DIALYSIS SESSION COULD NOT TAKE PLACE. THE PATIENT HAD TO BE OPERATED AGAIN TO PLACE A NEW CATHETER OF THE SAME BRAND. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698559 ↗
• MalfunctionFeb 3, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS PLACED ON (B)(6) AND DURING THE DIALYSIS SESSION ON (B)(6), THE NURSE NOTICED THE PRESENCE OF AIR BUBBLES IN THE CIRCUIT. THERE WAS BLOOD AT THE CONNECTION BETWEEN THE TRIANGLE AND THE ARTERIAL LINE. IT WAS SAID THAT THEY WERE FORCE TO SHORTEN THE "MEETING" SINCE THE ISSUE WAS JUST ON THE ARTERIAL LINE. A CATHETER REMOVAL WAS THEREFORE PERFORMED ON DECEMBER 15 AS WELL AS THE PLACEMENT OF A NEW CATHETER (SAME MODEL). THE CATHETER WAS NOT REPAIRED. NO VISIBLE DAMAGE NOTED. THERE WAS NO BLOOD LOSS. NO BLOOD TRANSFUSION WAS REQUIRED. THE CATHETER WAS TREATED IDENTICALLY (SAME ASEPSIS, SAME HANDLING). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272160 ↗
• MalfunctionFeb 3, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS PLACED ON DECEMBER 9 AND DURING THE DIALYSIS SESSION ON DECEMBER 12, THE NURSE NOTICED THE PRESENCE OF AIR BUBBLES IN THE CIRCUIT. THERE WAS BLOOD AT THE CONNECTION BETWEEN THE TRIANGLE AND THE ARTERIAL LINE. IT WAS SAID THAT THEY WERE FORCE TO SHORTEN THE "MEETING" SINCE THE ISSUE WAS JUST ON THE ARTERIAL LINE. A CATHETER REMOVAL WAS THEREFORE PERFORMED ON DECEMBER 15 AS WELL AS THE PLACEMENT OF A NEW CATHETER (SAME MODEL). THE CATHETER WAS NOT REPAIRED. NO VISIBLE DAMAGE NOTED. THERE WAS NO BLOOD LOSS. NO BLOOD TRANSFUSION WAS REQUIRED. THE CATHETER WAS TREATED IDENTICALLY (SAME ASEPSIS, SAME HANDLING). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272146 ↗
• MalfunctionFeb 3, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS PLACED ON (B)(6) AND DURING THE DIALYSIS SESSION ON (B)(6), THE NURSE NOTICED THE PRESENCE OF AIR BUBBLES IN THE CIRCUIT. IT WAS SAID THAT A CATHETER REMOVAL WAS THEREFORE PERFORMED ON (B)(6) AS WELL AS THE PLACEMENT OF A NEW CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272134 ↗
• MalfunctionFeb 3, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, IT WAS OBSERVED DURING THE PATIENT'S HEMODIALYSIS SESSION THAT THE ARTERIAL LINE OF THE CATHETER WAS SUCKING AIR. THE DIALYSIS SESSION WAS THEREFORE STOPPED EARLY (NOT COMPLETED) AND THE CATHETER WAS CHANGED WITH SAME MODEL TO RESOLVE THE ISSUE. IT WAS SAID THAT THE CLINICAL CONSEQUENCES WERE THE INEFFECTIVENESS OF THE DIALYSIS SESSION WITH A CREATININE LEVEL OF 84ML/L IN POST SESSION AND FORTUNATELY THERE WERE NO IONIC OR VOLUME PROBLEMS. THE CATHETER WAS NOT REPAIRED. NOTHING UNUSUAL OBSERVED BEFORE USE. THE CATHETER WAS TREATED IDENTICALLY (SAME ASEPSIS, SAME HANDLING). THERE WAS NO BLOOD LEAKAGE, NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11271703 ↗
• MalfunctionJan 6, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, AT THE END OF INSERTION WHEN CONNECTING THE HUB WITH Y-PART WITH STRONG POWER, ASPIRATION WAS CARRIED OUT AND DRAWING AIR THROUGH THE CONNECTION POINT. THE CONNECTOR COULD ONLY BE CLOSED WITH GREAT EFFORT AND DURING THE SUBSEQUENT TEST. IT WAS STATED THAT THERE WAS A LEAK BETWEEN HUB AND Y-PART OF BOTH VENOUS AND ARTERIAL ADAPTER BUT HAS NO LUER ADAPTER ISSUE. THE DOCTOR DECIDED TO CLAMP THE CATHETER NEAR THE SKIN, CUT THE EXTRACORPOREAL END AND REPLACED IT WITH HUB AND Y-PART BY ANOTHER KIT FROM THE SAME SOLDER AND THE CATHETER WORKS FLAWLESSLY. IT WAS STATED THAT THE CATHETER WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. FLUSHING WAS DONE WITHOUT ANY PROBLEM USING THE STERILE NACL (SODIUM CHLORIDE) AND ALSO THE CLEANING AGENT USED ON THE DEVICE. BRAUNOL WAS THE CLEANING AGENT USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED. THE CATHETER WAS REPAIRED. THERE WAS NO TEGO UTILIZED. THERE WAS NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. T HERE WAS NO OTHER DEFECTS OR DAMAGES FOUND ON THE CATHETER WHERE THE LEAK WAS OBSERVED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123152 ↗
• MalfunctionDec 15, 2020Break; Break

  ACCORDING TO THE REPORTER, THE BIFURCATION AT THE HUB OF THE CATHETER WAS SUCKING AIR AND LEAKING BLOOD WHILE THE PATIENT WAS RECEIVING DIALYSIS. THE PRESSURE HAD TO BE SET AT 200. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013835 ↗
• MalfunctionDec 15, 2020Break; Break

  ACCORDING TO THE REPORTER, THE BIFURCATION AT THE HUB OF THE CATHETER WAS SUCKING AIR AND LEAKING BLOOD WHILE THE PATIENT WAS RECEIVING DIALYSIS. THE PRESSURE HAD TO BE SET AT 200. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013136 ↗
• MalfunctionDec 11, 2020Break; Break

  ACCORDING TO THE REPORTER, THE BIFURCATION AT THE HUB OF THE CATHETER WAS SUCKING AIR AND LEAKING BLOOD WHILE THE PATIENT WAS RECEIVING DIALYSIS. THE PRESSURE HAD TO BE SET AT 200. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10994360 ↗
• MalfunctionDec 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, THE BIFURCATE TOGETHER WITH THE EXTENSIONS DETACHED FORM THE CATHETER JUST AFTER THE CUFF. THEY HAD TO USE OF A NEW SET TO CHANGE THE MISSING PART. MANUAL COMPRESSION AND PLACEMENT OF A KOCHER FORCEPS DURING THE CHANGEOVER TO AVOID SIGNIFICANT BLOOD LOSS. TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 10977858 ↗
• InjuryOct 7, 2020Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6), 2020, DURING PROCEDURE OF THE CATHETER EXCHANGE OVER A WIRE UNDER GENERAL ANESTHESIA, THE SURGEON WOULD WITHDRAW THE CATHETER 2CM AND THEN CUT THE CATHETER AT THE LEVEL THAT WAS PREVIOUSLY BELOW THE SKIN. IN THIS FASHION, THE SURGEON WOULD NOT EXCHANGE A WIRE THROUGH A CATHETER THAT HAD BEEN EXPOSED OUTSIDE OF THE PATIENT¿S BODY. AFTER CUTTING THE CATHETER, THE SURGEON ADVANCED THE WIRE THROUGH THE CATHETER AND REMOVED THE REMAINDER OF THE CATHETER. THE SURGEON HAD A CLAMP ON THE CATHETER AND CUT IT. NO TIME DID THE SURGEON LOSE SIGHT OF ANY PORTION OF THE CATHETER. HOWEVER, THE SURGEON LOOKED INSIDE THE CATHETER, THERE WAS A DIFFERENT COLOR LINING IN THE CATHETER THAT THE HEALTH PROFESSIONAL WAS NOT USUALLY SEE. THIS WAS NOT THE TYPE OF CATHETER THE SURGEON THE SURGEON USUALLY EXCHANGES. A PAIR OF FORCEPS WAS USED TO PICK UP THE LINING BUT, IT FELT COMPLETELY ATTACHED TO THE INSIDE OF THE CATHETER. AT THE TIME, IT SEEMED THAT THIS WAS A DIFFERENT TYPE OF CATHETER WITH A DIFFERENT LINING IN IT. IT DID NOT OCCUR TO THE SURGEON THAT THIS COULD BE A FAULTY CATHETER. THE SURGEON THEN EXCHANGED THE CATHETER OVER THE WIRE. THE SURGEON ADVANCED THE NE

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 10645631 ↗
• InjuryOct 5, 2020Defective Device

  REVIEW OF THE EVENTS SURROUNDING THE INCIDENT WERE CONDUCTED AND REVIEW WITH THE SURGEON INVOLVED. WE HAVE CONCLUDED THAT THIS INCIDENT INVOLVED A POSSIBLE DEFECTIVE/MALFUNCTION CATHETER. AS DESCRIBED BY THE SURGEON, THE PROCEDURE OF THE CATHETER EXCHANGE OVER A WIRE (IF POSSIBLE) THE SURGEON WOULD WITHDRAW THE CATHETER 2CM AND THEN CUT THE CATHETER AT THE LEVEL THAT WAS PREVIOUSLY BELOW THE SKIN. IN THIS FASHION, THE SURGEON WOULD NOT EXCHANGE A WIRE THROUGH A CATHETER THAT HAS BEEN EXPOSED OUTSIDE OF THE PATIENT'S BODY. AFTER CUTTING THE CATHETER, THE SURGEON ADVANCED THE WIRE THROUGH THE CATHETER AND REMOVED THE REMAINDER OF THE CATHETER. THE SURGEON HAD A CLAMP ON THE CATHETER AND CUT IT. AT NO TIME DID THE SURGEON LOSE SIGHT OF ANY PORTION OF THE CATHETER. HOWEVER, LOOKING INSIDE THE CATHETER; THERE'S A DIFFERENT COLOR LINING IN THE CATHETER THAT THE SURGEON WAS NOT USED TO SEEING. THIS IS NOT THE TYPE OF CATHETER THE SURGEON USUALLY EXCHANGES. A PAIR OF FORCEPS WAS USED TO PICK UP THE LINING BUT, IT FELT COMPLETELY ATTACHED TO THE INSIDE OF THE CATHETER. THE SURGEON THEN EXCHANGED THE CATHETER OVER THE WIRE. THE SURGEON ADVANCED THE NEW CATHETER OVER THE SAME WIRE. THE FINAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10634418 ↗
• DeathJul 29, 2020Detachment of Device or Device Component; Infusion or Flow Problem; Detachment of Device or Device Component; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, (B)(4) DAYS POST INSERTION, THE PATIENTS HEART RATE DECREASED AND WAS IN THE 30¿S AROUND MIDNIGHT WHICH ALERTED THE NURSE VIA CENTRAL CARDIAC MONITORING DEPARTMENT WHO THEN SAW PATIENT SLUMPED OVER AT THE FOOT OF HIS BED WITH BLOOD DRIPPING ON TO THE FLOOR. THERE WAS A LARGE POOL OF BLOOD ON THE FLOOR WHERE THE PATIENT HAD EVIDENTLY BEEN BLEEDING FROM THE CATHETER FOR A WHILE. AFTER A REVIEW FROM THE NURSES, THE TUNNELED PORTION OF THE CATHETER WAS STILL IN THE PATIENT BUT THE HUB AND BOTH EXTENSION (THE TRIANGULAR WHITE HUB, LUMENS, CAPS, CLAMPS WERE ALL TOGETHER NOT ATTACHED TO THE TUBE) HAD BROKEN OFF AND LOOKED TO BE A CLEAN BREAK OF THE CATHETER AND NO ABNORMAL EDGES THAT INDICATE IT WAS PULLED APART VIOLENTLY. THEY WERE NOT ABLE TO GET A GOOD ESTIMATE OF THE BLOOD LOSS DUE TO THE EVENTS RIGHT AFTER THE PATIENT WAS DISCOVERED. THE STAFF¿S FEET WERE LITERALLY SLIDING AROUND ON THE FLOOR DUE TO THE BLOOD POOL ON THE FLOOR. THE PATIENT WAS VERY LARGE AND GIVEN HIS LOCATION ON HIS BED, STAFF HAD A LOT OF DIFFICULTY GETTING HIM BACK INTO THE BED IN ORDER TO PUT HIM IN A BETTER POSITION TO DO CHEST COMPRESSIONS AND ATTACH AED (AUTOMATED EXTERNAL DEFIBRILLA

  Patient problems: Death

  MAUDE report 10339392 ↗
• InjuryJul 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, TWO DAYS AFTER THE CATHETER WAS PLACED/INSERTED BY A VASCULAR SURGEON IN THE OPERATING ROOM (OR), THE MACHINE WAS ALERTED OF LOW PRESSURE AND THE PATIENT WAS LOSING BLOOD DUE TO THE CATHETER BEING SPLIT INTO TWO PARTS. IT WAS MENTIONED THAT THE CATHETER WAS BROKEN BELOW THE HUB ATTACHMENT WITH ONE PIECE IN THE BODY AND THE OTHER (EXTENSION/HUB) OFF OF THE CATHETER (THE HUB WITH LUMENS CAME AWAY FROM THE TUBE THAT¿S PLACED IN THE PATIENT¿S BODY, IT SEPARATED WHERE THE METAL PIECE WAS). THE BOTH THE ARTERIAL AND VENOUS LINES WERE ATTACHED TO THE LUMENS OF THE CATHETER, THEY WERE NOT REVERSED (RED WAS ATTACHED TO RED, BLUE WAS ATTACHED TO BLUE). IT WAS MENTIONED THAT WHEN THE CATHETER CAME APART PRIOR TO THE MACHINE ALARMING, BLOOD WAS ESCAPING FROM THE CATHETER AND FROM THE VENOUS LINE OF THE HD CIRCUIT AND THE BLOOD FLOWS WERE AT 400 ML/MIN WHEN THE EVENT OCCURRED. THE CATHETER WAS NOT REPAIRED. CHLORHEXIDINE GLUCONATE (CHG) WAS THE CLEANING AGENT USED ON THE DEVICE AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO OINTMENT WAS UTILIZED AT THE EXIT SITE AND BIOPATCH WITH CLEAR ADHESIVE DRESSING WHICH WAS SPECIFIC FOR CATHETERS THAT CAME IN A D

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10338291 ↗
• MalfunctionJul 22, 2020Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER HAD A LEAK FROM THE "WAVY PIECE" WHEN USED AT HIGH PRESSURE WHILE THE MACHINE AND BLOOD PUMP WAS RUNNING. IT WAS MENTIONED THAT THE CATHETER HAD SUCKED IN AIR AND BLOOD HAD LEAKED FROM THE BACK. THE CATHETER WAS REPAIRED, THEY WERE USING A 23 BUT THEN USED A 28 KIT TO REPAIR IT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 10310773 ↗
• MalfunctionApr 24, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING CONNECTION IN A PATIENT WITH END-STAGE RENAL DISEASE, THE INJECTION OF THE SALINE SOLUTION REVEALED THERE WAS A LEAK AT THE EXIT SITE OF THE VENOUS EXTENSION OF THE CATHETER. THERE WAS ALSO NO RETURN OF BLOOD ON THIS EXTENSION. THERE WERE NO DAMAGE OR HOLE NOTED WITH THE ARTERIAL AND VENOUS EXTENSION TUBE. THE CATHETER WAS NOT REPAIRED. THE INSERTION SITE WAS NOTED TO BE TREATED PRIOR TO PRODUCT PLACEMENT. THE VENOUS BRANCH WAS NOT USED FOR THE DIALYSIS SESSION AND THE PATIENT NEEDED A NEW CATHETER. IT WAS MENTIONED THAT THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, NOTHING DURING INSERTION, NO LEAK, THE DAY THE EVENT OCCURRED, NOTHING UNUSUAL OBSERVED WHEN THE DRESSING WAS REMOVED. IT WAS STATED THAT THE CLEANING AGENT USED IN THE CATHETER WAS NACL9/.. AND LOCK TAUROLOCK UROKINASE 25000UI/ML.WAS UTILIZED WITH THE DEVICE. THERE WAS NO REPEATED CLAMPING PERFORMED DURING THE EVENT AND THE CLAMP WAS NOT MOVED PERIODICALLY. THERE WAS NO BLOOD LOSS. THERE WAS NO SUTURE NEEDLING DONE OR ADDITIONAL HANDLING DURING INSERTION BY VASCULAR SURGEONS. TREATMENT WAS NOT COMPLETED. IT WAS STATED THAT THERE WAS A RISK OF INFECTION AND THROMBOTIC B

  Patient problems: No Code Available; No Consequences Or Impact To Patient; No Information

  MAUDE report 9997781 ↗
• MalfunctionApr 7, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING USE, A HAIRLINE CRACK WAS NOTED ON THE LUER ADAPTER CAUSING A LEAK. THE CATHETER WAS REPAIRED WITH A REPAIR KIT. TEGO WAS NOT UTILIZED; NO INSTRUMENT WAS USED TO TIGHTEN AND LOOSEN THE ADAPTERS. OCTENISEPT WAS THE CLEANING AGENT USED. IT WAS STATED THAT BD Q-SYTE CONNECTORS WERE USED AND THIS COULD BE THE REASON WHY THE LUER ADAPTER BROKE AFTER A TIME OF USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932149 ↗
• MalfunctionApr 2, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS TREATMENT IN A PATIENT WITH KIDNEY DISEASE, THE DEVICE WAS FOUND TO HAVE AN AIR LEAK IN THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO BLOOD LEAK. IT WAS NOTED THAT ADDITIONAL PROCEDURES WERE DONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9918012 ↗
• MalfunctionFeb 4, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AFTER DIALYSIS TREATMENT, THE NURSE FOUND A LEAK ON THE CONNECTION BETWEEN SILICONE EXTENSION AND CONNECTOR OF THE EXTENSION TUBE (VENOUS LUMEN). IT WAS STATED THAT TREATMENT HAS BEEN COMPLETED BEFORE THE LEAKAGE WAS SEEN. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS BEING UTILIZED. FLUSHING WAS DONE WITH SALINE 0.9% AND THE RESULTS WERE NORMAL. TEGO WAS NOT UTILIZED AND NO LUER ADAPTER ISSUE. THE CATHETER WAS REPAIRED USING THE REPAIR KIT. OCTENISEPT ALCOHOL FREE WAS THE CLEANING AGENT USED ON THE DEVICE AND THE ADAPTERS. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO OINTMENT APPLICATION IN THE AREA. REPEATED CLAMPING WAS NOT PERFORMED BUT THE CLAMP MOVED PERIODICALLY. THERE WAS NO BLOOD LOSS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS. THERE WAS NO OTHER INTERVENTION DONE ASIDE FROM USING THE REPAIR KIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664899 ↗
• MalfunctionJan 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING SERVICING, THE CATHETER WAS FOUND TO BE BROKEN AND THERE WAS LEAKAGE. IT WAS ALSO STATED THAT THE PATIENT WAS SUFFERING FROM DEMENTIA WHEREIN THE PATIENT WAS NOTED TO BE PICKING AND PULLING HIS DIALYSIS CATHETER. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE DEVICE. THE CATHETER WAS REPLACED IN ORDER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9548795 ↗
• MalfunctionJul 19, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THE NURSE SAW A LEAK IN THE VENOUS EXTENSION TUBE WHICH IS LOCATED AT THE JUNCTION OF EXTENSION TUBES AND BIFURCATE. IT WAS STATED THAT THE CATHETER WAS REPAIRED BY A NEW MATERIAL FROM A KIT WITH THE SAME LOT NUMBER TO RESOLVE THE ISSUE. THE TREATMENT WAS PROCEEDED AND COMPLETED. THERE WAS NO BLOOD LOSS, BUT ONLY THE SOLUTION WAS DROPPED INTO THE DRESSING. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THEY USED OCTENISEPT AS A CLEANING AGENT FOR THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808375 ↗
• MalfunctionJul 19, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THE NURSE SAW A LEAK AT THE VENOUS EXTENSION TUBE WHICH IS LOCATED AT THE JUNCTION OF EXTENSION TUBE AND BIFURCATE. IT WAS STATED THAT THE CATHETER WAS REPAIRED BY A NEW MATERIAL FROM A KIT WITH UNKNOWN LOT NUMBER TO RESOLVE THE ISSUE. THE TREATMENT WAS PROCEEDED AFTER THE REPLACEMENT OF CATHETER AND THE TREATMENT WAS COMPLETED. THERE WAS BLOOD LOSS OF LESS THAT 1(ONE) ML(MILLILITER). TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807760 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123196. One submission often covers many models, so check the product and lot details in each record.

• Z-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1635-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, aph
• Z-1634-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute a
• Z-1314-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1313-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1315-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1312-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-2374-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
• Z-2371-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
• Z-2375-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
• Z-2372-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P

…and 34 more.