Palindrome 8888145016PRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521157996), received between Jan 4, 2018 and Jan 27, 2026 — classified as 1 death, 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

48 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ENTIRE ARTERIAL LUER END DETACHED FROM THE CATHETER DURING DIALYSIS; NO ONE WAS ACTIVELY TOUCHING THE LINE AT THAT TIME. THE LUER LOCK CONNECTION REMAINED SECURE, AND THE LUER END CAME AWAY WITH THE DIALYSIS LINE. LINE INFECTION FOLLOWING DETACHMENT. THE ADMISSION FOR THE LINE WAS EXCHANGE. THE NURSE WAS BESIDE THE PATIENT SWAPPING DIALYSIS CANISTERS AND WAS ABLE TO IMMEDIATELY CLAMP THE LINE WITH THE FINGERS AND LINE CLAMP TO PREVENT BLOOD LOSS. THE NURSE CLAMPED THE LINE WITH THE CLAMP IN HAND. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE HOSPITAL. THE NEW LUMEN WAS INSERTED, AND THE PATIENT WAS ADMITTED FOR LINE EXCHANGE IN RADIOLOGY. THE PATIENT DEVELOPED A BACTEREMIA FOLLOWING THE INCIDENT. THE CATHETER WAS NOT REPAIRED. THE CLEANING AGENT USED ON THE DEVICE WAS 2% CHLORHEXIDINE IN 70% ALCOHOL (CHLORPREP USED FOR THE EXIT SITE, HEXIHUB CLINELL WIPES) USED FOR CONTACT TIME DISINFECTION OF THE DEVICE. THE PRODUCT WAS TESTED/INSPECTED PRIOR TO USE. THE PATIENT WAS ALIVE AND STABLE.

  Patient problems: Bacteremia

  MAUDE report 24189976 ↗
• DeathDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ENTIRE VENOUS LUER END DETACHED FROM THE CATHETER DURING DIALYSIS. THE LUER LOCK CONNECTION REMAINED SECURE, AND THE LUER END CAME AWAY WITH THE DIALYSIS LINE. THE PRODUCT WAS TESTED/INSPECTED PRIOR TO USE. THE NURSES ATTENDED TO THE PATIENT ON HEARING A COUGHING SOUND AND FOUND BLOOD LOSS AROUND THE PATIENT. RESUSCITATION COMMENCED AND CONTINUED BY PARAMEDICS BUT WAS UNSUCCESSFUL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23849602 ↗
• MalfunctionAug 20, 2025Break; Break

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS PLACED INTO THE PATIENT, THE CATHETER FAILED, AND THEY WERE NOT ABLE TO HEMODIALYZE. IT WAS ALSO STATED THAT THERE WAS A CRACK AND LEAK OBSERVED AT THE BLUE (VENOUS) ADAPTER. A BLOOD LEAK OCCURRED AT THE BIFURCATE. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE CATHETER WAS NOT REPAIRED. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849306 ↗
• MalfunctionSep 30, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, 2 DAYS AFTER THE CATHETER HAD BEEN IN PLACE, DURING DIALYSIS TREATMENT, PINPOINT HOLES IN THE MIDDLE OF BOTH ARTERIAL AND VENOUS LUMENS WERE NOTED. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. 2% CHLORHEXIDINE AND 70% ALCOHOL WERE THE CLEANING AGENTS USED ON THE DEVICE, AND IT WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT(S) ALLOWED TO DRY THOROUGHLY, AND THEY DID NOT APPLY OINTMENTS. THE CLAMP WAS MOVED PERIODICALLY. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH CHLORHEXIDINE PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS EXPLANTED. THE LINE WAS REPLACED WITH A TEMPORARY 13.5-CENTIMETER INTERNAL JUGULAR (IJ) CATHETER ON THE SAME DAY, INTERVENTIONAL RADIOLOGY WAS NOTIFIED, AND TREATMENT WAS COMPLETED. THERE WAS BLOOD LOSS SPRAYED FROM THE LINE. BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 20340872 ↗
• MalfunctionAug 27, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE DIALYSIS SESSION, THE DOCTOR CALLED IN AND ASKED IF THE CATHETER KIT WAS STILL AVAILABLE AS THE BIFURCATE HAD A HOLE. IT WAS ALSO STATED THAT THE BIFURCATE HAS A LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. PRIMING WAS DONE; THERE WERE NO ABNORMALITIES DURING ASPIRATION WITH THE SYRINGE. OCTENISEPT WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. DIALYSIS ACCESSORIES FROM FRESENIUS WERE THE OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS EVENTUAL BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER WAS NOT REPLACED. HOWEVER, THE EXCHANGE OF THE CATHETER WAS THE INTERVENTION/TREATMENT AND THE REMEDIAL ACTION REQUIRED AS A RESULT OF THE EVENT. THE PROCEDURE CONTINUED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 20078021 ↗
• MalfunctionFeb 23, 2024Material Puncture/Hole; Insufficient Flow or Under Infusion; Material Puncture/Hole; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE REASON FOR THE EMERGENCY CHANGE WAS THAT THERE HAD BEEN TWO MASSIVE ASPIRATIONS OF AIR OVER THE ARTERIAL LEG OF THE CATHETER, DIALYSIS WAS AUTOMATICALLY STOPPED, THE PATIENT WAS NOT HARMED BUT THERE WAS A RISK OF A MASSIVE AIR EMBOLISM. THE PHYSICIAN THEN CHECKED THE CATHETER AFTER THE CHANGE AND FOUND A LEAKAGE OF THE ARTERIAL LEG IN THE ATTACHMENT AREA. IT WAS MENTIONED THAT THE PATIENT WAS REFERRED TO THE DOCTOR BY AN EXTERNAL HOSPITAL SHORTLY BEFORE CHRISTMAS FOR A CATHETER CHANGE AND THE 14.5 FR (FRENCH) 28 CENTIMETER CATHETER WAS NOT INSERTED AT THE PHYSICIAN'S FACILITY BUT INSERTED FROM A DIFFERENT HOSPITAL. THE REFERRING PHYSICIAN WAS FROM THE INTERNAL MEDICINE DEPARTMENT OF OTHER HOSPITAL (ON DUTY AT THE TIME), THE CATHETER WAS NOT REPAIRED AND THE DEVICE REPLACEMENT FROM THE WARD WAS CARRIED OUT ON (B)(6) 2023 WITHOUT ANY PROBLEMS, A VECTOR FLOW CATHETER FROM THE COMPETITOR'S COMPANY WAS INSERTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765756 ↗
• MalfunctionJan 11, 2024Migration; Migration

  ACCORDING TO THE REPORTER, WHILE THE PATIENT WAS AT HOME AND IN-BETWEEN THE DIALYSIS TREATMENT, THE PATIENT REPORTED THAT THE CATHETER'S LINE FELL OUT, WHICH MEANT THAT IT WAS MOVED OUT OF PLACE. IT WAS STATED THAT THE PATIENT WAS SITTING AT HOME WHILE WATCHING TV (TELEVISION) WHEN THE PATIENT FELT SOMETHING MOVED DOWN TO THE PATIENT'S CHEST, AND WHEN THE PATIENT LOOKED DOWN, THE LINE WAS COMPLETELY OUT. THIS MEANT THAT THE ENTIRE LENGTH OF THE LINE CAME OUT, AND NO PART OF THE LINE REMAINED IN THE PATIENT. THERE WAS NO SECUREMENT WING ISSUE, AND THE CATHETER DID NOT MOVE OUT OF PLACE DUE TO THE SECUREMENT WING ISSUE. THE PATIENT PRESENTED TO WARD 108 OF THE FACILITY FOR FURTHER ASSESSMENT BUT DECLINED THE TEMPORARY LINE INSERTION OR INTERVENTION. THE PATIENT WAS ADVISED TO TAKE LOKELMA 10 GRAMS (G) AS THE SERUM POTASSIUM WAS 6.3 MMOL/L (MILLIMOLE/LITER), THE UREA WAS 35.8 MMOL/L AND THE CREATININE WAS 933 UMOL/L (MICROMOLE/LITER). IT WAS ALSO STATED THAT THE PATIENT FAILED TO PRESENT FOR BLOODS ON (B)(6) 2023. THE SERUM POTASSIUM WAS UP TO 6.7 MMOL/L (UREA 43.8MMOL/L) ON NEXT SET OF BLOODS ON (B)(6) 2023. THE PATIENT WAS BROUGHT INTO EMERGENCY DEPARTMENT BY AMBULANCE ON (B)(6) 202

  Patient problems: Discomfort; Erythema; Insufficient Information

  MAUDE report 18494969 ↗
• InjuryJun 10, 2023Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, SOON AFTER IMPLANTATION, THE CATHETER HAD DEFECT WITH FLOW PROBLEMS (INSUFFICIENT ASPIRATION) FOR BOTH LUMENS SO A DIALYSIS WAS NOT POSSIBLE. IT WAS ALSO DIFFICULT TO FLUSH THE LINE WITH THE SYRINGE. IT ALSO HAD INTERDIALYTIC FILLING OF BOTH LEGS WITH BLOOD, DESPITE CORRECT INSTILLATION OF TAUROLOCK TO HEMODIALYSIS END. THE LEAK COULD NOT BE VERIFIED EVEN BY PROVOCATION/PRESSURE, EVEN AFTER ANOTHER BLOCKAGE AND ANOTHER WAITING PERIOD OF 1 HOUR. STANDARD BLOCK WITH TAUROLIDINE HEPARIN OR UROKINASE (ACTILYSE CATHFLO, SYNERKINASE, TAUROLIDINE UROKINASE) WERE NOT ABLE TO PROVIDE ADEQUATE IMPROVEMENT. THERE WAS BLOOD RETURN BEFORE FLUSHING THE SYRINGE. NOTHING UNUSUAL OBSERVED AT THE BEFORE USE. FLUSHING WAS DONE PRIOR TO USE AND AFTER WITHDRAWAL OF THE BLOCK SOLUTION, BLOOD WAS ASPIRATED AND THE PATENCY OF THE CATHETER WAS CHECKED WITH NACL (SODIUM CHLORIDE). THE CATHETER WAS NOT REPAIRED. OTHER PRODUCTS USED WITH THE DEVICE WERE BLOCK SOLUTIONS AND DIALYSIS SYSTEM WITH LUER LOCK CONNECTED TO STANDARD. THERE WAS NO P ROBLEM WITH THE LUER LOCK CLOSURE OF THE CATHETER. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEV

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Unintended Radiation Exposure

  MAUDE report 17102040 ↗
• MalfunctionFeb 13, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, IT WAS STATED THAT ANOTHER CATHETER WAS PLACED AND IT WAS NOTED THAT THERE WAS HOLE IN THE RED EXTENSION TUBE IN THE SAME PLACE. THE PRODUCT WAS NOT REPAIRED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707404 ↗
• MalfunctionApr 5, 2018Hole In Material; Hole In Material

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE DEVICE HAD A PIN HOLE IN THE VENOUS LIMB OF THE SILICONE EXTENSIONS. THERE WAS A BLOOD LEAK NOTICED AT THE START OF THE TREATMENT. THE CATHETER HAD BEEN IN PLACED IN THE LEFT FEMORAL VEIN FOR 81 DAYS. IT WAS REPORTED THAT THE DIALYSIS WAS DISCONTINUED AND A NEW CATHETER WAS INSERTED. THERE WAS NO PATIENT INJURY REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7400653 ↗
• MalfunctionJan 4, 2018Hole In Material; Hole In Material

  ACCORDING TO THE REPORTER, PRIOR TO DIALYSIS, TWO SMALL PINHOLES WERE DISCOVERED ON THE VENOUS EXTENSION TUBE. THE CATHETER WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7166486 ↗

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-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI 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-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision 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-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI 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-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-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

…and 33 more.