Palindrome 8888123404PRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521157774), received between Feb 6, 2019 and Mar 8, 2024 — classified as 1 death, 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (13 reports).

2 FDA recall records name this device's identifier, 2 still open.

47 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.

Recalls naming this device

1. Apr 23, 2025Class IIOpen, Classified

   Potential breach of sterile barrier packaging.

   Z-1885-2025 · Root cause: Packaging · Recall details · FDA record ↗

2. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1312-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING IRRIGATION WITH A 10 ML SYRINGE VIA THE ARTERIAL ROUTE TO START TREATMENT, THE CATHETER TIP BROKE AND NO LONGER HELD. AFTERWARDS, IT ENDED UP IN THE STERILE FIELD. THE CATHETER WAS IMMEDIATELY PINCHED AND A PAIR OF CLAMP SCISSORS WAS USED TO PREVENT BLEEDING. IT WAS IMPOSSIBLE TO REPAIR THE CATHETER, SO IT WAS CHANGED IN ANGIO THE SAME DAY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18869817 ↗
• MalfunctionMay 22, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER HAD BEEN IMPLANTED INTO THE PATIENT FOR ONE DAY. DURING DIALYSIS, IT WAS FOUND THAT THERE WAS A HOLE OR TEAR AT THE EXTENSION TUBE NEAR THE BIFURCATE (CLAMPING SITE OF THE CATHETER) WHICH HAD CAUSED BLOOD LEAK. IT WAS SUGGESTED THAT CLAMPING (WHICH WAS NECESSARY) MAY HAVE CAUSED THE TEAR. THE CATHETER WAS NOT REPAIRED AND ALCOHOL PAD WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. FLUSHING WAS DONE AND HAD A NORMAL/GOOD RESULT. THE CATHETER WAS REPLACED/EXCHANGED TO RESOLVE THE ISSUE AND PROCEDURE WAS COMPLETED. THERE WAS BLOOD LOSS OF ABOUT 200 ML AND INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981858 ↗
• MalfunctionMay 8, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT RIGHT TUNNELED HEMODIALYSIS CATHETER EXCHANGE FOLLOWED BY DIALYSIS AT THE HOSPITAL INPATIENT DIALYSIS UNIT, WHERE AIR WAS NOTED IN THE RED ARTERIAL LINE. THE DIALYSIS WAS HALTED, AND THE HEMODIALYSIS CATHETER WAS REMOVED INTACT. IT WAS STATED THAT CATHETER INSPECTION AND SALINE INJECTION DEMONSTRATED SMALL PINPOINT HOLE IN THE CLEAR TUBING OF THE RED LUMEN NEAR THE WHITE CLAMP. THE APPROXIMATE AGE OF THE DEVICE WAS 1 YEAR OLD. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16889752 ↗
• InjuryMar 30, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN PATIENT WITHDREW THE CLOSING SOLUTION FROM THE ARTERIAL CATHETER PRIOR TO THE START OF HOME HEMODIALYSIS TREATMENT, THE PATIENT NOTICED THAT THERE WAS BLOOD ON THE SURGICAL FIELD AND A BLOOD AND AIR MIXTURE IN THE SYRINGE WERE NOTED. PATIENT STOPPED AND NOTIFIED THE HOME THERAPY NURSE. THEY IMMEDIATELY CLAMPED ARTERIAL PATH. PATIENT DID NOT REQUIRE HOSPITALIZATION AS THE PATIENT ONLY CAME TO HOSPITAL FOR NEW CATHETER INSERTION. THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16649521 ↗
• MalfunctionFeb 15, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE WRITER WAS CLEANING AND DOING THE PREP FOR THE PATIENT PRIOR TO HOOKING HIM UP TO THE MACHINE. PATIENT WAS CURRENTLY ON A CATHETER ALWAYS RUNNING REVERSE DURING HIS RUN, PORTS WERE ASPIRATED. THEY FLUSHED BOTH PORTS AND DID PUSH AND PULL MOTION TO SEE IF THE LUMENS WERE SLUGGISH OR WERE GOOD. THE WRITER NOTICED THAT THERE WERE TWO SMALL HOLES LOCATED ON THE VENOUSLUMEN/EXTENSION TUBE WHERE THE LUMEN WAS CLAMPED (MIDDLE PART OF THE TUBE) AND DUE TO THE OCCURRENCE UNABLE TO START THE TREATMENT. THERE WAS NO REPORTED LEAK ONLY HOLES WERE VISUALLY OBSERVED. IT WAS MENTIONED THAT FLUSHING WAS NOT THE ISSUE. THE ISSUE WAS NOTICED DURING THE PRE-HEMODIALYSIS LINE ASSESSMENT, THERE WERE TWO HOLES. TEGO WAS UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. CHLORHEXIDINE 2% WITH 70% ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE CLAMPS WERE MOVED AFTER EACH TREATMENT. LINE NEEDED TO BE EXCHANGED FOR A NEW DEVICE. A NEW CATHETER WAS INSERTED TO RESOLVE THE ISSUE (THE NEW CATHETER DID NOT HAVE HOLES IN IT). TREATMENT WAS NOT COMPLETED. THE PATIENT WAS POTENTIAL FOR INFECTION, EMBOLISM OR BLOOD LOSS BUT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380623 ↗
• InjuryDec 29, 2022Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED IN THE PATIENT UNDER ONE YEAR, DURING DIALYSIS RUN, AIR WAS PULLED INTO THE CATHETER THROUGH A SMALL HOLE IN THE ARTERIAL LIMB OF THE CATHETER WHICH CREATED BUBBLES IN THE DIALYSIS CIRCUIT, CAUSING THE PATIENT TO HAVE TO COME FROM TRAIL TO HOSPITAL FOR AN IMMEDIATE ADMISSION AND REPLACEMENT. THE CATHETER WAS NOT REPAIRED AND THERE WAS A FLUID/BLOOD LEAK FOUND AT THE SHAFT DURING FLUSHING. THERE WAS NO LEAK AT THE JUNCTION OF THE BIFURCATE AND THE CATHETER. TEGO WAS UTILIZED. CHLORHEXIDINE WITH ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. FLUSHING WAS DONE PRIOR TO USE AND IT WAS DISCOVERED THAT THERE WAS A LEAK ISSUE. TEGO <(>&<)> 3M TEGADERM IV ADVANCED WERE UTILIZED WITH THE DEVICE ASIDE FROM CIRCUIT. THE EXIT SITE WAS NOT TREATED WITH ANY MEDICATION. 3M TEGADERM IV ADVANCE WAS THE WOUND DRESSING USED TO THE PATIENT. THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NO OINTMENT UTILIZED. THE PATIENT W

  Patient problems: Insufficient Information

  MAUDE report 16074681 ↗
• MalfunctionApr 29, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN THE PATIENT WAS ASPIRATING FROM THE CATHETER PRIOR TO HOOKING UP TO THE DIALYSIS IN PREPARATION FOR PERFORMING DIALYSIS AT HOME, IT WAS FOUND THAT THE LINE DEVELOPED A LARGE HOLE AND LEAK ON THE VENOUS LUMEN OF THE CATHETER (IN THE FLEXIBLE SILICONE PORTION WHERE IT MET THE HARD PLASTIC PIECE RIGHT BELOW THE HUB). THE CATHETER WAS NOT REPAIRED. THE CATHETER WAS REPLACED. 3M SOLUPREP WIPES 2% CHLORHEXIDINE GLUCONATE AND 70% ISOPROPYL ALCOHOL WERE THE CLEANING AGENTS USED ON THE CATHETER IN ITS ENTIRETY. TEGO WAS UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. NO OINTMENT WAS UTILIZED AND PATIENT WORE A DRESSING THAT COVERED THE EXIT SITE BUT IT WAS NOT THE AREA WHERE THE HOLE WAS LOCATED. AS THE PATIENT PERFORMED HEMODIALYSIS AT HOME, PATIENT WAS RESPONSIBLE FOR ALL MAINTENANCE. CLEANING AGENTS WERE NOT SWITCHED OVER THE LIFE OF THE CATHETER AND CLEANING AGENTS WERE NOT MIXED. THE SITE NEVER USED SEPSIDERM AND THERE WAS NO PROTOCOL CHANGE FOR CLEANING AGENTS USED RECENTLY. THERE WAS BLOOD LOSS AND RISK OF INFECTION. THE PATIENT REQUIRED TRANSPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253127 ↗
• InjuryOct 20, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE FIRST ONE ENDED UP CAUSING AN AIR EMBOLISM DUE TO FAULTY SHEATH. WHEN THEY REMOVED THE WIRE AND INNER DILATOR, THE DOCTOR HEARD A HISSING SOUND (CLINICAL SYMPTOM THAT INDICATED SUSPICION OF AIR EMBOLISM). NEW SHEATH (SECOND SHEATH MENTIONED) FROM SHELF STOCK WAS USED TO REPLACED THE DEFECTIVE SHEATH. THE PATIENT WAS INTUBATED AND VENTILATED AS A DIRECT RESULT OF THE AIR EMBOLISM AND TURNED ON THE LEFT SIDE. NO OTHER DIAGNOSIS/CONDITION CAUSE THE PATIENT TO REQUIRE INTUBATION/VENTILATION. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. AIR EMBOLISM WAS THE PATIENT SYMPTOM OR COMPLICATION ASSOCIATED WITH THIS EVENT. THERE WERE NO ADDITIONAL INTERVENTIONS/TREATMENTS REQUIRED DUE TO THE AIR EMBOLISM. THERE WAS NO CLEANING AGENT(S) USED ON THE DEVICE. THERE WAS NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT OBSERVED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO FLUSHING DONE PRIOR TO USE. PATIENT WAS STATED TO HAVE RECOVERED.

  Patient problems: Air Embolism

  MAUDE report 12666684 ↗
• MalfunctionOct 20, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, ON JULY 8 AT AROUND 4:00 IN THE MORNING, THE PATIENT NOTED A LEAK ON THE PIN POINT HOLE (FIRST HOLE FOUND) OF THE EXTENSION TUBE ON VENOUS SIDE OF CVC, "CENTRAL VENOUS CATHETER" (BELOW THE ¿Y¿). IT WAS STATED THAT THE PATIENT WOKE UP WITH BLOOD (SOME BLEEDING) IN BED AND RUNNING DOWN HIS ARM. ON JULY 9, EARLY IN THE MORNING, THE PATIENT DISCOVERED A SECOND HOLE WHICH WAS AT LEAST AN INCH ABOVE THE CLAMP (ABOVE THE ¿Y¿). IT WAS SAID THAT THE PATIENT PERFORMS NOCTURNAL HEMODIALYSIS TREATMENT AT HOME BUT THE HOLES WERE NOTICED WHEN NO TREATMENT WAS BEING PERFORMED. THE CATHETER WAS NOT REPAIRED. THE CATHETER WAS NOTED TO BE FELT SOMEWHAT SOFTER/MALLEABLE THAN USUAL. THERE WAS NO LUER ADAPTER ISSUE. CLAMPS WERE NOT MOVED TO A NEW LOCATION AFTER EACH TREATMENT, HOWEVER, THE CLAMP WERE MOVED ON OCCASION; EVERY FEW WEEKS. 2% OF CHLOREHEXIDINE WITHOUT ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE WHICH WAS ALLOWED TO DRY. NO OINTMENT WAS IN USE. TEGO WAS NOT UTILIZED. INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT WITH CHLORHEXADINE. OTHER PRODUCTS IN USE WERE 2% CHLORHEXIDINE WITHOUT ALCOHOL, 3M TEGADERM ADVANCED DRESSING AND F RESENIUS BL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10708356 ↗
• MalfunctionSep 3, 2020Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CATHETER WAS PREPPED IN A NORMAL FASHION. THE STYLETS WERE PLACED AND CATHETER WAS INSERTED. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STYLETS, ONE STYLET WAS VERY DIFFICULT TO REMOVE. PHYSICIAN PULLED BACK ON STYLET AND ULTIMATELY THE BODY OF THE STYLET APPEARED STRETCHED AND BROKEN. IT WAS STATED THAT AN EXCESSIVE FORCE WAS USED TO REMOVE CAUSING THE STYLET BROKE. THE ENTIRE CATHETER AND STYLETS WERE REMOVED. SECOND CATHETER WAS OPENED AND PLACED SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO EXTENSION OF SURGERY TIME. IT WAS STATED THAT FLUSHING WAS DONE PRIOR TO USE. THE STYLET THAT WAS USED WAS THE ONE INCLUDED IN THE KIT AND THE DIMENSION OF THE STYLET/CATHETER MATCH THE ONE PRINTED ON THE PRODUCT INSERT/PACKAGING. THERE WAS LESS THAN 10 MILLILITER OF BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO CATHETER LEAK. THE CATHETER WAS NOT REPAIRED, NO TEGO UTILIZED AND NO LUER ADAPTER ISSUE. NO UNUSUAL OBSERVED PRIOR TO USE, NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, NO ISSUES WITH THE INSERTION OF THE STYLET, NO DAMAGE ON THE PACKAGE, NO OTHER DAMAGE/DEFECTS NOTED ON THE DEVICE. THERE WAS NO PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10486891 ↗
• MalfunctionDec 26, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, A SMALL PUNCTURE HOLE WAS FOUND AT THE BACK OF ONE OF THE CATHETER LUMENS, AND A FEW DROPS OF BLOOD WERE NOTED BY THE NURSE ON THE PATIENTS SHIRT. CATHETER LUMEN WAS NOT FLUSHED BUT ASPIRATED, CHLOROHEXIDINE SWABS ARE USED AS CLEANING AGENT. IT WAS ALSO REPORTED THAT THE PATIENT REQUIRED A REWIRE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 9521941 ↗
• MalfunctionDec 26, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, A SMALL PUNCTURE HOLE WAS FOUND AT THE BACK OF ONE THE CATHETER LUMENS, IT WAS ALSO REPORTED THAT COUPLE OF DAYS PRIOR, A FEW DROPS OF BLOOD WERE NOTED ON THE PATIENTS SHIRT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9519948 ↗
• MalfunctionOct 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THEY FLUSHED THE VENOUS LUMEN OF THE CATHETER WITH 10CC NORMAL SALINE AND THE BLUE HUB OF THE LUMEN THAT THE TEGO CONNECT TO BECOME COMPLETELY DISLODGED FROM THE LUMEN. IT WAS STATED THAT THE PATIENT WAS HAVING ARTERIAL PRESSURE ALARMS AND WAS DISCONNECTED TO FLUSH THE LUMENS PRIOR TO HAVING THE LINES REVERSED. THE CLAMP WAS OPEN AT THE TIME TO ENABLE FLUSHING. THE STAFF WHO WAS FLUSHING THE LINE IMMEDIATELY USED HIS FINGERS TO OCCLUDE THE LINE AND PROCEEDED TO CLAMP. IT WAS STATED THAT THE PATIENT DID NOT RECEIVE HIS DIALYSIS TREATMENT FOR THAT DAY AND HAD TO COME BACK THE NEXT DAY FOR REINSERTION OF A DIFFERENT MANUFACTURERS CATHETER. THE CATHETER WAS NOT REPAIRED, CHLORHEXIDINE WAS THE CLEANING AGENT USED. TEGO WAS UTILIZED, THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9170247 ↗
• MalfunctionSep 17, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS PINKHOLE/BLOOD LEAK IN THE EXTENSION TUBING BELOW THE CLAMP. CHLORAPREP WAS USED ON THE DEVICE AS THE CLEANING AGENT AND WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. TEGO WAS UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND AFTER FLUSHING. NO ANY OTHER DEFECTS OR DAMAGES WERE FOUND ON THE CATHETER WHERE THE LEAK WAS OBSERVED. THE AMOUNT OF BLOOD LOST WAS NEGLIGIBLE AND BLOOD TRANSFUSION OR OTHER INTERVENTION/TREATMENT WAS NOT REQUIRED. THEY HAD TO REPLACE THE CATHETER TO RESOLVE THE ISSUE AND IT WAS USED SUCCESSFULLY AND THE TREATMENT WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075251 ↗
• MalfunctionJul 29, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THERE WERE 2 PIN-PRICK SIZE HOLES NOTED ON THE SOFT PART OF THE VENOUS LUMEN/EXTENSION TUBE AND HAD A LEAK. IT WAS REPORTED THAT STAFF ARE TAUGHT TO MOVE CLAMPS TO A NEW LOCATION AFTER EACH TREATMENT, THOUGH THIS IS SOMETHING THAT IS NOT ROUTINELY DOCUMENTED. THE PRODUCTS USED WITH THE DEVICE INCLUDE: 3M SOLUPREP (2% CHG/70% ISOPROPYL ALCOHOL) SWAB OR WIPE (FOR EXIT SITE CARE AND CATHETER CLEANSING) WHICH HAS A MINIMUM OF APPROXIMATELY 3 MINUTES OF DRYING TIME, MOLNLYCKE MEPORE DRESSING, STERILE NS (10CC OR 20CC SYRINGE), MEDXL CITRAFLOW 4%, AND ALTEPLASE PRN (AS NEEDED). THERE WAS NO INTERVENTION REQUIRED AS A RESULT OF THE EXTENSION TUBE HOLE, THERE WAS NO REPORTED BLOOD LOSS AND NO TRANSFUSION WAS DONE. THE CATHETER WAS NOT REPAIRED, THE PATIENT HAD TO BE REWIRED/REINSERTED WITH A NEW ONE, TEGO WAS NOT UTILIZED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8839713 ↗
• MalfunctionJul 3, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THERE WAS A BARELY VISIBLE (TINY) PUNCTURE HOLE FOUND ON THE UNDERSIDE OF THE SOFT LUMEN OF THE CATHETER DURING DIALYSIS TREATMENT. IT WAS ALSO STATED THAT THE NURSE SAW ONLY SMALL DROPS OF BLOOD ON THE PATIENT'S CLOTHING. THE TREATMENT WAS STOPPED AND A SINGLE-LUMEN DIALYSIS TREATMENT WAS COMPLETED. CLAMPS WERE MOVED ABOVE THE PUNCTURED HOLES UNTIL REINSERTION OF THE GUIDE WIRE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8759082 ↗
• DeathFeb 6, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING HD (HEMODIALYSIS) TREATMENT, THE CATHETER CRACKED. A CRACK OF LESS THAN 2MM WAS NOTED IN THE LUMEN BETWEEN THE HUB AND THE PORTS (CLEAR PART UNDER THE CLAMPS) AND CAUSED LEAKING OF BLOOD DURING FLUSHING, THERE WAS BLOOD LOSS OF 1ML, NO INTERVENTION WAS DONE AND NO TRANSFUSIONS REQUIRED. IN ORDER TO RESOLVE THE ISSUE, A NEW CATHETER WAS USED. THERE CATHETER WAS IN PLACE FOR 2 YEARS. THE PATIENT'S STATUS WAS INITIALLY FINE POST DIALYSIS, HOWEVER WEEKS AFTER THE PATIENT DIED DUE TO MYOCARDIAL INFARCTION (MI) AND THE EVENT WAS CONFIRMED TO BE NOT RELATED TO THE DEVICE ISSUE.

  Patient problems: Death

  MAUDE report 8311545 ↗

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-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-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-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-2373-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
• 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
• 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-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-0330-2016 · Oct 14, 2015 · Terminated
  Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic he

…and 32 more.