Palindrome 8888145014PRecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10884521157972), received between Aug 29, 2023 and Nov 13, 2025 — classified as 4 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Break” (50 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 8, 2022Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, AFTER THE CATHETER HAD BEEN IMPLANTED, IT WAS FOUND TO HAVE A CRACK AT THE LUER CONNECTOR. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NORMAL RESULT. THERE WERE OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. AS A REMEDIAL ACTION AND INTERVENTION/TREATMENT, THE CATHETER WAS REPLACED. THE PROCEDURE WAS CONTINUED AND COMPLETED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550414 ↗
• MalfunctionNov 13, 2025Break; Break

  ACCORDING TO THE REPORTER, TEN DAYS AFTER CATHETER INSERTION, THE CATHETER CONNECTOR RUPTURED, PREVENTING THE PATIENT FROM RECEIVING NORMAL DIALYSIS. THE PATIENT COMPLAINED TO THE HOSPITAL. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THE TYPE OF CLEANING AGENT USED ON THE DEVICE WAS IODINE SOLUTION. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23549615 ↗
• MalfunctionNov 12, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE TIP BROKE AFTER CATHETER INSERTION. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS A LUER ADAPTER ISSUE AND IT WAS ALSO STATED THAT A CRACK WAS OBSERVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538655 ↗
• MalfunctionNov 12, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE, A CRACK WAS OBSERVED IN THE CATHETER TIP AT VENOUS LUER ADAPTER (BLUE). THE CATHETER HAS BEEN IN PLACE FOR 6 MONTHS. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THE CLEANING AGENT WAS NOT ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. TEGO WAS NOT UTILIZED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE TUBE WAS REPLACED. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536004 ↗
• MalfunctionNov 12, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER A LONG-TERM TUBE IMPLANTATION, LESS THAN SIX MONTHS OF USE, THE HEAD WAS CRACKED. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE AND ADAPTER. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT DONE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. HAND WAS THE METHOD USED TO TIGHTEN THE ADAPTERS. AS A REMEDIAL ACTION, THE CATHETER WAS REPLACED. NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532991 ↗
• MalfunctionOct 24, 2025Break; Protective Measures Problem; Break; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING INSERTION INTO THE PATIENT, IT WAS REPORTED BY THE INTERVENTIONAL RADIOLOGY DEPARTMENT THAT A VALVE ON THE CATHETER KIT DID NOT WORK CORRECTLY. THE VALVE ISSUE OCCURRED WITHIN THE PEEL-AWAY SHEATH THAT WAS INCLUDED IN THE 19 CM (CENTIMETERS) DUAL LUMEN PERMANENT TUNNELED DIALYSIS CATHETER KIT. WHEN THE DOCTOR WENT TO INSERT THE CATHETER THROUGH THE PEEL-AWAY, THE AMOUNT OF BLOOD COMING OUT WAS ABNORMAL. AFTER THE CATHETER WAS SUCCESSFULLY PLACED AND THE PEEL-AWAY WAS REMOVED FROM THE PATIENT, THE DOCTOR OBSERVED THAT THE PEEL-AWAY DID NOT HAVE THE VALVE INSIDE OF IT AS IT USUALLY WOULD. NO MALFUNCTION WAS OBSERVED IN THE CLAMP, CATHETER SHAFT, OR BIFURCATE.THERE WAS NO ISSUE WITH THE LUER ADAPTER. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ANESTHESIA TIME WAS NOT EXTENDED BY GREATER THAN 30 MINUTES. THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. THE WOUND DRESSING UTILIZED WAS A COMPETITOR¿S GAUZE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS NORMAL. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. AS THE DEVICE WAS NEWLY IMPLANTED, THE INSERTION SITE WAS TRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378395 ↗
• MalfunctionAug 1, 2025Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PATIENT INSERTION, THE BLUE EXTENSION TUBE WAS REPOSITIONED AND BROKE OFF NEAR THE ADAPTER AFTER THE CONTRAST WAS INJECTED. THE CATHETER WAS NOT REPAIRED. NO CLEANING AGENT WAS USED ON THE DEVICE, ONLY A SALINE FLUSH. THE RESULT OF THE FLUSHING PRIOR TO USE WAS NORMAL. A TEGO WAS UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE, AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. THE CATHETER WAS REPLACED ON THE SAME DAY WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT NUMBER AS THE REMEDIAL ACTION, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AS A RESULT OF THE EVENT, AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22693291 ↗
• MalfunctionJun 30, 2025Break; Break

  ACCORDING TO THE REPORTER, BEFORE PREPARING FOR DIALYSIS, A RUPTURE OF THE RED LUER CONNECTOR WAS OBSERVED. THERE WAS A LEAK AND CRACK AT THE RED ARTERIAL LUER ADAPTER. FLUSHING WAS DONE WITH CRACK RESULTS ON THE CONNECTOR. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THE CATHETER WAS REPAIRED BY REPLACING THE TEMPORARY CATHETER OF DOMESTIC BRANDS. THE KIT WAS NOT USED. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357483 ↗
• MalfunctionJun 27, 2025Break; Break

  ACCORDING TO THE REPORTER, WHEN PREPARING FOR DIALYSIS, IT WAS OBSERVED THAT THE CATHETER HAD A CRACK BLUE (VENOUS) LUER ADAPTER. IT WAS ALSO STATED THAT THERE WAS A LEAK AT THE LUER ADAPTER. THE CATHETER WAS REPAIRED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. TEGO WAS UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352513 ↗
• MalfunctionJun 27, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE PREPARATION FOR DIALYSIS, IT WAS FOUND THAT THE CATHETER HAD A BROKEN CONNECTOR, AND THE PHYSICIAN WAS NOTIFIED IMMEDIATELY. IT WAS STATED THAT THERE WAS A CRACK AT THE RED (ARTERIAL) END. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. THERE WAS NO INSTRUMENT USED TO LOOSEN AND TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE LUER ADAPTER WAS TIGHTENED BY HAND. THE CLEANING AGENT USED TO CLEAN THE LUER ADAPTER WAS IODOPHOR. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED BY USING A DOMESTIC TEMPORARY LUER ADAPTER. THE KIT WAS NOT USED. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351996 ↗
• MalfunctionJun 27, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE PREPARATION FOR DIALYSIS, IT WAS FOUND THAT THE CATHETER HAD A BROKEN CONNECTOR, AND THE PHYSICIAN WAS NOTIFIED IMMEDIATELY. IT WAS STATED THAT THERE WAS A CRACK AT THE RED (ARTERIAL) END. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. THERE WAS NO INSTRUMENT USED TO LOOSEN AND TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE LUER ADAPTER WAS TIGHTENED BY HAND. THE CLEANING AGENT UTILIZED TO CLEAN THE LUER ADAPTER WAS IODOPHOR. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED BY REPLACING THE LUER ADAPTER. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351961 ↗
• MalfunctionJun 27, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING FLUSHING WHILE PREPARING FOR DIALYSIS, THE BLUE (VENOUS) LUER ADAPTER WAS FOUND TO BE BROKEN/CRACKED AND LEAKING. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTER. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE METHOD UTILIZED TO TIGHTEN THE ADAPTERS WAS BY HAND. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THEY NOTIFIED THE PHYSICIAN, AND THE CATHETER WAS REPAIRED BY REPLACING THE NATIONAL BRAND TEMPORARY LUER ADAPTER, AND NO REPAIR KIT WASUSED. THE REPLACEMENT DOMESTIC TEMPORARY LUER ADAPTER WAS SOURCED FROM A DOMESTIC TEMPORARY TUBE USED IN HOSPITAL PRODUCTS. AFTER THE REPAIR, TREATMENT WAS COMPLETED. NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351059 ↗
• MalfunctionJun 27, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING FLUSHING WHILE PREPARING FOR DIALYSIS, THE RED (ARTERIAL) LUER ADAPTER WAS FOUND TO BE BROKEN/CRACKED AND LEAKED. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTER. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE ADAPTERS WERE TIGHTENED BY HAND. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THEY NOTIFIED THE PHYSICIAN; THE CATHETER WAS REPAIRED BY REPLACING THE DOMESTIC TEMPORARY LUER ADAPTER, AND NO REPAIR KIT WAS USED. THE REPLACEMENT DOMESTIC TEMPORARY LUER ADAPTER WAS SOURCED FROM DOMESTIC TEMPORARY TUBES, WHICH WERE HOSPITAL PRODUCTS. AFTER THE REPAIR, TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350940 ↗
• MalfunctionJun 27, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING FLUSHING WHILE PREPARING FOR DIALYSIS, THE RED (ARTERIAL) LUER ADAPTER WAS FOUND TO BE BROKEN/CRACKED AND LEAKING. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTER. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE METHOD UTILIZED TO TIGHTEN THE ADAPTERS WAS BY HAND. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THEY NOTIFIED THE PHYSICIAN, AND THE CATHETER WAS REPAIRED BY REPLACING THE DOMESTIC TEMPORARY LUER ADAPTER, AND NO REPAIR KIT WAS USED. THE REPLACEMENT DOMESTIC TEMPORARY LUER ADAPTER WAS SOURCED FROM DOMESTIC TEMPORARY TUBES, WHICH WERE HOSPITAL PRODUCTS. AFTER THE REPAIR, TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS AS A RESULT OF THE EVENT, AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350822 ↗
• MalfunctionJun 27, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING FLUSHING WHILE PREPARING FOR DIALYSIS, THE BLUE (VENOUS) LUER ADAPTER WAS FOUND TO BE BROKEN/CRACKED AND LEAKING. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTER. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE ADAPTERS WERE TIGHTENED BY HAND. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THEY NOTIFIED THE PHYSICIAN, AND THE CATHETER WAS REPAIRED BY REPLACING THE DOMESTIC TEMPORARY LUER ADAPTER, AND NO REPAIR KIT WAS USED. THE REPLACEMENT DOMESTIC TEMPORARY LUER ADAPTER WAS SOURCED FROM A DOMESTIC TEMPORARY TUBE USED IN HOSPITAL PRODUCTS. AFTER THE REPAIR, TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350796 ↗
• MalfunctionJun 26, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, PRIOR TO STARTING THE TREATMENT, THE HEPARIN CAP WAS OPENED WITHOUT ANY MANIPULATION. A NOTICEABLE CRACK WAS OBSERVED AT THE ARTERIAL (RED) END OF THE PATIENT'S CATHETER. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE PHYSICIAN REPAIRED THE CATHETER BY REPLACING THE CATHETER CONNECTOR, WHICH WAS THE REMEDIAL ACTION AND THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342988 ↗
• MalfunctionJun 26, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, A CRACK WAS OBSERVED AT THE VENOUS (BLUE) LUER ADAPTER OF THE PATIENT'S CENTRAL VENOUS CATHETER USED FOR HEMODIALYSIS. THERE WAS NO LEAK, AND A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS REPAIRED WHEN THE CONNECTOR WAS SUBSEQUENTLY REPLACED AS THE REMEDIAL ACTION AND THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT, AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342960 ↗
• MalfunctionJun 26, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE MORNING OF THE EVENT DAY, A PATIENT IN ZONE 5 FOUND THAT THERE WAS A CRACK ON THE VENOUS (BLUE) END OF THE LONG-TERM CATHETER BEFORE BEING PUT ON THE MACHINE. THE PHYSICIAN WAS NOTIFIED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER WAS REPAIRED BY REPLACING THE CONNECTOR IN THE WARD ON THE SAME DAY AS THE REMEDIAL ACTION AND THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT, AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342684 ↗
• MalfunctionJun 26, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, DURING DIALYSIS IN ZONE 6 IN THE MORNING, BLEEDING WAS OBSERVED AT THE PATIENT¿S CATHETER INSERTION SITE. AN IMMEDIATE ASSESSMENT REVEALED A CRACK AT THE VENOUS PORT OF THE LONG-TERM CATHETER. THE PHYSICIAN WAS PROMPTLY NOTIFIED, AND THE PATIENT UNDERWENT RE-VENIPUNCTURE TO CONTINUE DIALYSIS. THE VENOUS CONNECTOR WAS REPLACED AT 9:00 AM ON (B)(6) AS AN INTERVENTION. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION AND INTERVENTION, THE CATHETER WAS REPAIRED. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342125 ↗
• MalfunctionJun 26, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, DURING DIALYSIS IN ZONE 2, BLEEDING WAS OBSERVED AT THE PATIENT¿S CATHETER INSERTION SITE WITH THE LONG-TERM CATHETER. AN IMMEDIATE EXAMINATION REVEALED A CRACK AT THE VENOUS PORT OF THE LONG-TERM CATHETER. THE PHYSICIAN WAS PROMPTLY NOTIFIED, AND THE PATIENT UNDERWENT RE-VENIPUNCTURE TO CONTINUE DIALYSIS. AS A REMEDIAL ACTION AND INTERVENTION, THE VENOUS CONNECTOR WAS REPLACED AT 9:00 A.M. ON FEBRUARY 18TH. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS REPAIRED BY REPLACING THE VENOUS CONNECTOR. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342051 ↗
• MalfunctionJun 26, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, PRIOR TO THE PROCEDURE, THE HEPARIN CAP WAS OPENED WITHOUT ANY MANIPULATION, REV EALING A NOTICEABLE TEAR (CRACK) AT THE PATIENT'S VENOUS (BLUE) CATHETER END. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER WAS REPAIRED BY REPLACING THE CATHETER CONNECTOR BY THE PHYSICIAN, WHICH WAS THE REMEDIAL ACTION AND THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341740 ↗
• MalfunctionJun 24, 2025Break; Break

  ACCORDING TO THE REPORTER, IN PREPARATION FOR DIALYSIS, BEFORE FLUSHING, A CRACK, BREAK, AND LEAK WERE OBSERVED IN THE BLUE (VENOUS) LUER ADAPTER/JOINT/CONNECTOR. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR, AND IT WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE METHOD UTILIZED TO TIGHTEN THE ADAPTERS WAS BY HAND. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. THE CATHETER WAS REPAIRED BY REPLACING THE LUER ADAPTER WITH A DOMESTIC TEMPORARY LUER ADAPTER, AND TREATMENT PROCEEDED AND WAS COMPLETED. A REPAIR KIT WAS NOT USED. THE ATTENDING PHYSICIAN WAS NOTIFIED. THERE WAS NO BLOOD LOSS AS A RESULT OF THE EVENT, AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322615 ↗
• MalfunctionJun 24, 2025Break; Break

  ACCORDING TO THE REPORTER, WHEN PREPARING FOR DIALYSIS BEFORE CONNECTION, IT WAS FOUND THAT THE CATHETER HAD A CRACK IN THE BLUE (VE NOUS) LUER ADAPTER/JOINT, AND THE ATTENDING PHYSICIAN WAS NOTIFIED. IT WAS ALSO STATED THAT IT HAD A LEAK AT THE LUER ADAPTER. THE CRACK WAS ALSO OBSERVED PRIOR TO USE. FLUSHING WAS DONE, AND LEAKAGE OCCURRED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED. THE CONNECTOR WAS REPLACED. THE KIT WAS NOT USED. THE TREATMENT WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WERE NO PATIENT SYM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321889 ↗
• MalfunctionJun 24, 2025Break; Break

  ACCORDING TO THE REPORTER, WHEN PREPARING FOR DIALYSIS, A CRACK WAS FOUND IN THE JOINT, AND THE ATTENDING PHYSICIAN WAS NOTIFIED. THERE WAS A LEAK, AND A CRACK WAS OBSERVED AT THE LUER (RED ARTERIAL) ADAPTER. CRACKED WAS THE UNUSUAL THING OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCED USE ON THE DEVICE. FLUSHING WAS DONE, AND CRACKS WERE OBSERVED BEFORE FLUSHING. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS NOT UTILIZED. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320115 ↗
• MalfunctionJun 23, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE UNDERGOING A DRESSING CHANGE OF THE LONG-TERM CATHETER PRIOR TO HEMODIALYSIS, A TEAR, WHICH MEANT A CRACK, WAS OBSERVED AT THE VENOUS END/LUER ADAPTER OF THE CHRONIC CENTRAL VENOUS CATHETER. THERE WAS NO LEAK. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. AS THE INITIAL DISPOSITION, THE DOCTOR ON DUTY INFORMED THE PATIENT AND FAMILY MEMBERS OF THE ACTUAL SITUATION AND CONTACTED THE SUPERIOR DOCTOR. THE PATIENT WAS TOLD TO GO TO THE WARD, AND THE CATHETER WAS REPAIRED BY REPLACING THE VENOUS END CONNECTOR THE NEXT DAY. THE PHYSICIAN WAS INFORMED THAT THE VENOUS END WAS FIRST MADE ACCORDING TO THE DOCTOR'S INSTRUCTIONS, AND THE ARTERIAL END WAS GIVEN FOR DIALYSIS TREATMENT. DURING TREATMENT, CLOSE OBSERVATION WAS PERFORMED FOR THE PRESENCE OF BLEEDING AND AIR. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307584 ↗

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-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-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• 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-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-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-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-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-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-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

…and 33 more.