Palindrome 8888145015PRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10884521157989), received between Jan 21, 2021 and Sep 17, 2025 — classified as 1 death, 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PATIENT'S SURGICAL PROCEDURE, THE GUIDEWIRE BECAME LODGED IN THE PUNCTURE NEEDLE AND COULD NOT BE REMOVED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION AND INTERVENTION, AFTER REPLACING THE GUIDEWIRE AND RE-PUNCTURING, NORMAL OPERATION WAS RESTORED. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23079166 ↗
• MalfunctionJul 21, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE RED AND BLUE HEADS WERE FOUND TO BE BROKEN. THERE WAS A CRACK AT THE LUER ADAPTER. THERE WAS NO LEAK. THE CATHETER WAS NOT REPAIRED. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. IODINE WAS THE CLEANING AGENT(S) THAT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE, AND THE BLUE AND RED CONNECTOR HAD LEAKAGE. NO EXCESSIVE FORCED USE ON THE DEVICE. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED. 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 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 22555538 ↗
• MalfunctionJun 23, 2025Break; Defective Component; Break; Defective Component

  ACCORDING TO THE REPORTER, ON (B)(6) 2024, THE PATIENT UNDERWENT ARTERIOVENOUS FISTULA CREATION FOR HEMODIALYSIS IN THE DEPARTMENT, FOLLOWED BY REGULAR HEMODIALYSIS SESSIONS SINCE THEN. ON (B)(6) 2025, DURING A DIALYSIS SESSION, BLEEDING WAS OBSERVED AT THE CONNECTION SITE OF THE DIALYSIS CIRCUIT AND THE LONG-TERM INTERNAL JUGULAR VEIN CATHETER. EXAMINATION REVEALED A CRACK AT THE CATHETER CONNECTION INTERFACE. INVESTIGATION SUGGESTED THAT THE MISMATCH IN MATERIAL COMPATIBILITY BETWEEN THE LONG-TERM CATHETER AND THE HEMODIALYSIS CIRCUIT COMPONENTS LED TO THE DAMAGE OF THE CATHETER JUNCTION, MEANING THE DISPOSABLE DIALYSIS TUBING DID NOT MATCH WITH THE INTERFACE OF THE CATHETER FOR HEMODIALYSIS. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED WITH ANYTHING PRIOR TO PRODUCT PLACEMENT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE LONG-TERM INTERNAL JUGULAR VEIN CATHETER WAS REPAIRED BY REPLACING THE INTERFACE, AND AN ARTERIOVENOUS FISTULA FOR HEMODIALYSIS WAS RECONSTRUCTED AS INTERVENTION. THE NEW CATHETER CONNECTOR WAS INSTALLED, AND NO FURTHER BLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307377 ↗
• MalfunctionJun 18, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT LONG-TERM INTERNAL JUGULAR VEIN CATHETERIZATION FOR HEMODIALYSIS USING A CHRONIC CATHETER ON (B)(6) 2024, FOLLOWED BY REGULAR HEMODIALYSIS SESSIONS. ON THE DAY OF THE EVENT, BLEEDING WAS OBSERVED AT THE CONNECTION POINT BETWEEN THE LONG-TERM CATHETER AND THE DIALYSIS CIRCUIT DURING A SESSION. EXAMINATION REVEALED A CRACK AT THE INTERFACE VENOUS (BLUE). INVESTIGATION SUGGESTED THAT THE MISMATCH IN MATERIAL COMPATIBILITY BETWEEN THE LONG-TERM CATHETER AND THE DIALYSIS CIRCUIT COMPONENTS CAUSED THE CONNECTOR TO RUPTURE. THERE WAS A CRACK AND A LEAK. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NORMAL RESULTS. NO EXCESSIVE FORCED USE ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THE CONNECTOR WAS PROMPTLY REPLACED, AND NO FURTHER BLEEDING WAS OBSERVED. ADDITIONALLY, AN ARTERIOVENOUS FISTULA WAS CREATED TO NEUROVASCULAR ACCESS FOR ONGOING DIALYSIS. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22257025 ↗
• MalfunctionJun 16, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT LONG-TERM CHRONIC CATHETER PLACEMENT FOR RENAL DIALYSIS IN THE ENDOCRINE AND NEPHROLOGY DEPARTMENT ON (B)(6) 2025, FOLLOWED BY ROUTINE HEMODIALYSIS POSTOPERATIVELY. ON THE DAY OF THE EVENT, BLEEDING WAS OBSERVED AT THE JUNCTION BETWEEN THE DIALYSIS CATHETER AND THE LONG-TERM CATHETER INTERFACE DURING DIALYSIS. INVESTIGATION SUGGESTED THAT THE MISMATCH IN MATERIAL COMPATIBILITY BETWEEN THE LONG-TERM CATHETER AND THE HEMODIALYSIS CIRCUIT COMPONENTS LED TO DAMAGE AT THE CATHETER CONNECTION. AFTER REPLACING THE LONG-TERM CATHETER CONNECTOR, BLEEDING DID NOT RECUR. ADDITIONALLY, AN ARTERIOVENOUS FISTULA WAS CREATED TO ENSURE VASCULAR ACCESS FOR ONGOING DIALYSIS. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AND CRACK AT THE VENOUS(BLUE) ADAPTER. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NORMAL RESULTS. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. AS A REMEDIAL ACTION AND INTERVENTION, THE CONNECTOR W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214214 ↗
• MalfunctionJun 9, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER THE CATHETER WAS IMPLANTED AND USED FOR A PERIOD OF TIME DURING A DIALYSIS SESSION, IT WAS FOUND THAT THE RED END OF THE CATHETER LUER CONNECTOR HAD CRACKS. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS DONE WITH NORMAL RESULTS. THERE WAS NO LEAK. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. DIALYSIS TUBING WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. THE CATHETER WAS REPLACED AS AN INTERVENTION. 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 22172960 ↗
• MalfunctionJun 9, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER THE CATHETER WAS IMPLANTED AND USED FOR A PERIOD OF TIME, IT WAS OBSERVED PRIOR TO USE THAT THE RED END OF THE CATHETER LUER CONNECTOR HAD CRACKS. IT WAS ALSO STATED THAT THE CATHETER HAD A LEAK AT THE LUER ADAPTER. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS DONE WITH NORMAL RESULTS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT, AND TEGO WAS NOT UTILIZED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. BY HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. BLOODLINES WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WASPOVIDONE-IODINE. THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTER WAS IODOPHOR. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT. THERE WAS NO REMEDIAL ACTION PERFORMED. THERE WERE NO BLOOD TRANSFUSIONS REQUIRED DUE TO THE EVENT. THE CATHETER HAS BEEN IN PLACE FOR 2 MONTHS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172827 ↗
• MalfunctionJun 9, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, DURING DIALYSIS TREATMENT, A CRACK IN THE BLUE/VENOUS LUER ADAPTER WAS FOUND. THERE WAS A LEAK AT THE LUER ADAPTER. IODOPHOR WAS THE CLEANING AGENT THAT WAS USED ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. A TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER HAD BEEN IN PLACE FOR ABOUT 2 MONTHS. THE ADAPTERS WERE TIGHTENED BY HAND. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS NORMAL. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. IODOPHOR WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS, AND THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO REMEDIAL ACTION WAS PERFORMED TO ADDRESS THE ISSUE, AND THE WHOLE CATHETER WAS NOT REPLACED. THE DIALYSIS 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 IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167531 ↗
• MalfunctionMay 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, IT WAS FOUND THAT THE CATHETER HAD A BROKEN BLUE (VENOUS) LUER ADAPTER. IT WAS STATED THAT THE BLUE (VENOUS) LUER ADAPTER HAD A CRACK AND A LEAK. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS UNREMARKABLE. THE CATHETER WAS NOT REPAIRED, AND TEGO WAS NOT UTILIZED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE OTHER PRODUCTS UTILIZED WITH THE DEVICE, THE CUSTOMER WERE USING A COMPETITOR'S EXTENSION LINES WITH THE CATHETER AND A COMPETITOR'S CAPS, AND ALSO CIRCUITS. THE PATIENT WAS NOT TREATED UNDER GENERAL OR LOCAL ANESTHESIA. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEVICE IN ITS ENTIRETY. LAVANIDE WAS IN DEMAND FOR OINTMENT, WHICH WAS UTILIZED AT THE EXIT SITE. THE WOUND DRESSING UTILIZED WAS A LEUKOMED PATCH, WHICH DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENTS WERE ALLOWED TO DRY COMPLETELY BEFORE OINTMENT APPLICATION. THE CLEANI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096495 ↗
• MalfunctionMay 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, IT WAS OBSERVED THAT THE CATHETER HAD A BROKEN BLUE (VENOUS) LUER ADAPTER AND HUB. IT WAS STATED THAT THERE WAS A CRACK AT THE VENOUS ADAPTER AND HUB. THERE WAS ALSO A LEAK AT THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, A TEAR WAS FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS DONE WITH UNREMARKABLE RESULTS. TEGO WAS NOT UTILIZED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE PATIENT WAS NOT TREATED UNDER GENERAL OR LOCAL ANESTHESIA. THERE WERE OTHER PRODUCTS UTILIZED WITH THE DEVICE, THE CUSTOMER WAS USING A COMPETITOR'S EXTENSION LINES WITH THE CATHETER AND A COMPETITOR'S CAPS AND ALSO CIRCUITS. THE CLEANING AGENT USED WAS OCTENISEPT. OCTENISEPT WAS ALSO TYPICALLY UTILIZED TO CLEAN THE CATHETER IN ITS ENTIRETY. THE OINTMENT THAT WAS UTILIZED AT THE EXIT SIDE WAS LAVANIDE. THE WOUND DRESSING UTILIZED WAS A LEUKOMED PATCH, WHICH DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA AND DRES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096306 ↗
• MalfunctionMay 13, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS LEAKY. IT WAS ALSO STATED THAT THE VENOUS ACCESS PULLED AIR. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22015581 ↗
• MalfunctionMay 6, 2025Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE CATHETER WAS LEAKY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21966066 ↗
• MalfunctionMar 27, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, BEFORE THE OPERATION, THE CATHETER WAS CHECKED, AND TRACHOMA (SAND HOLE) WAS FOUND ON THE ARTERIAL END OF THE EXTENSION TUBE NEAR THE LUER ADAPTER. FLUSHING WAS PERFORMED PRIOR TO USE, AND LEAKAGE WAS OBSERVED AT THE ARTERIAL END OF THE EXTENSION TUBE. THERE WAS NO LUER ADAPTER ISSUE, AND NO LEAK AT THE BIFURCATION. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. NOTHING ELSE UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS WERE USED WITH THE DEVICE. NO EXCESSIVE FORCE WAS APPLIED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT, AND TEGO WAS NOT USED. NO CLEANING AGENT WAS USED. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION, IT WAS REPLACED WITH ANOTHER ONE WITH THE SAME PRODUCT ID ON THE SAME DAY AS THE EVENT. THE OPERATION WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS PERFORMED. NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 21708173 ↗
• MalfunctionMar 13, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE GUIDEWIRE SPLIT UP OR UNRAVELED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. T HE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21593990 ↗
• MalfunctionMar 7, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS, THERE WAS A CRACK AND A SMALL AMOUNT OF OOZING BLOOD AT THE CATHETER PORT. THE LEAK LOCATION WAS AT THE EXIT SITE OF THE VENOUS PORT. THE CATHETER WAS NOT REPAIRED BUT WAS REPLACED WITH ANOTHER FROM THE SAME LOT AND ID. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547239 ↗
• MalfunctionMar 3, 2025Break; Break

  ACCORDING TO THE REPORTER DURING HEMODIALYSIS, THE PATIENT NOTICED A SMALL AMOUNT OF BLEEDING FROM THE BLUE ORIFICE. IT WAS FOUND THAT THE CATHETER PORT OF THE HEMODIALYSIS TUBE HAD A CRACK. NO UNUSUAL ISSUES WERE OBSERVED WITH THE DEVICE PRIOR TO USE, AND NO OTHER DAMAGE WAS FOUND AT THE TIME OF THE EVENT. FLUSHING WAS PERFORMED BEFORE USE, AND NO ISSUES WERE DETECTED. NO OTHER PRODUCTS WERE UTILIZED, AND NO EXCESSIVE FORCE WAS APPLIED. ADDITIONALLY, NO CLEANING AGENT WAS USED ON THE DEVICE, WHILE IODINE WAS THE CLEANING AGENT USED TO CLEAN THE ADAPTERS. IT WAS MENTIONED THAT THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY BEFORE APPLYING OINTMENT TO THE AREA. THE FITTING WAS TIGHTENED BY HAND. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED, AND THE CONNECTOR WAS REPLACED. DIALYSIS WAS COMPLETED AFTER THE REMEDIAL ACTION. THERE WAS AN APPROXIMATE BLOOD LOSS OF 1 ML, BUT A BLOOD TRANSFUSION WAS NOT PERFORMED. NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501982 ↗
• MalfunctionFeb 5, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, AN ALERT FROM THE PHARMACY FOR INDOOR USE ON OVERCONSUMPTION OF FIBRINOLYTIC (ACTILYSIS) SINCE THE BEGINNING OF JANUARY. IN THE SERVICE CALL, IT WAS STATED THAT THERE WAS AN INCREASE IN BLOCKED CATHETERS (PLACED IN ANOTHER ESTABLISHMENT). THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER HAS BEEN PLACED FOR THREE AND A HALF MONTHS. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES. THE OCCLUSION WAS DUE TO THROMBOSIS. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. ACTILYSE WAS THE REMEDIAL ACTION DONE (CURRENTLY THE PATIENT HAS PASSED ON A FISTULA). THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THE PATIENT HAD NOT BEEN HOSPITALIZED. AND THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 21313911 ↗
• MalfunctionFeb 5, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, AN ALERT FROM THE PHARMACY FOR INDOOR USE ON OVERCONSUMPTION OF FIBRINOLYTIC (ACTILYSIS) HAS BEEN IN PLACE SINCE THE BEGINNING OF JANUARY. IN THE SERVICE CALL, IT WAS STATED THAT THERE WAS AN INCREASE IN BLOCKED CATHETERS (PLACED IN ANOTHER ESTABLISHMENT). THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER HAS BEEN PLACED FOR ALMOST THREE MONTHS. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS EXCESSIVE FORCE USE ON THE DEVICE. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES. THE OCCLUSION WAS DUE TO THROMBOSIS. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. ACTILYSE WAS THE REMEDIAL ACTION PERFORMED. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THE PATIENT HAD NOT BEEN HOSPITALIZED, AND THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 21313844 ↗
• MalfunctionJan 20, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER IMPLANTATION, THE RED (ARTERIAL) LUER ADAPTER HAD A CRACK AND BLOOD LEAK. THE CATHETER WAS NOT REPAIRED. CHLORHEXIDINE ACID AQUEOUS SOLUTION WAS THE CLEANING AGENT USED ON THE DEVICE. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS GOOD. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE TREATMENT WAS COMPLETED. THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT 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 21191130 ↗
• MalfunctionJan 16, 2025Material Puncture/Hole; Operating System Becomes Nonfunctional; Material Puncture/Hole; Operating System Becomes Nonfunctional

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, BEFORE THE PATIENT WAS READY TO PERFORM THE HEMODIALYSIS, A ROUTINE EXAMINATION OF THE CATHETER WAS PERFORMED BY MEDICAL STAFF, AND A CRACK WAS FOUND AT THE CATHETER END INTERFACE WHICH DID NOT CAUSE DIRECT PHYSICAL INJURY TO THE PATIENT AS IT WAS FOUND BEFORE USE. IMMEDIATELY DISCONTINUED THE USE OF THE CATHETER AND REPLACED IT WITH A NEW CRACK-FREE CATHETER WITH THE SAME LOT AND ID ON THE SAME DAY OF THE EVENT AS A REMEDIAL ACTION. THE PROCEDURE WAS COMPLETED. IT WAS EXPLAINED AND PATIENT WAS REASSURED IN DETAIL TO ENSURING THE PATIENT WAS INFORMED OF THE EVENT AND PANIC WAS REMOVED. A FULL INSPECTION OF THE SAME BATCH OF CATHETERS IN STOCK WAS PERFORMED, AND NO OTHER CRACKS WERE IDENTIFIED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168333 ↗
• MalfunctionJan 2, 2025Break; Break

  ACCORDING TO THE REPORTER, ABOUT FOUR MONTHS AFTER THE NEW CATHETER WAS IMPLANTED, ON THE DAY OF THE EVENT, DURING DIALYSIS, A LEAK WAS FOUND ON THE LUER ADAPTER AND A CRACK WAS OBSERVED IN RED (ARTERIAL) LUER ADAPTER. THE CATHETER WAS NOT REPAIRED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061266 ↗
• MalfunctionOct 22, 2024Product Quality Problem; Difficult to Remove; Unraveled Material; Product Quality Problem; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING CATHETER PLACEMENT, THE GUIDEWIRE WAS KINKED, INTERTWINED AND THE OPERATION COULD NOT BE COMPLETED SMOOTHLY. THERE WAS NO LEAK. IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED WITH THE SAME LOT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506583 ↗
• MalfunctionOct 4, 2024Break; Break

  ACCORDING TO THE REPORTER, CRACKS IN THE BACK END (LUER ADAPTER) OF THE CATHETER WERE NOTED. ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. A REPAIR KIT WAS USED TO RESTORE THE CATHETER TO WORKING CONDITION, AND THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20375263 ↗
• MalfunctionOct 4, 2024Break; Break

  ACCORDING TO THE REPORTER, AFTER USE, CRACKS IN THE BACK END (LUER ADAPTER) OF THE CATHETER WERE NOTED. THERE WAS BLOOD LEAK AT THE SITE. ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS TESTED/VISUALLY INSPECTED PRIOR TO USE. THE DURATION OF USE WAS GREATER THAN ONE YEAR. THE DEVICE WAS NOT REMOVED OR REPLACED. A REPAIR KIT WAS USED TO RESTORE THE CATHETER TO WORKING CONDITION, AND THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20367815 ↗
• MalfunctionSep 20, 2024Filling Problem; Contamination /Decontamination Problem; Filling Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, IT WAS OBSERVED THAT THE VENOUS LEG/LUMEN LOOKED DIFFERENT. THERE WAS A PIECE OF GLUE/OBSTRUCTION IN THE VENOUS LUMEN (BLUE CONNECTOR OF THE CATHETER). THE SURGEON AND THE OR (OPERATING ROOM) ASSISTANT DID NOT TRUST THE PRODUCT; THEREFORE, THEY DECIDED NOT TO USE THE CATHETER. THERE WAS NO DAMAGE TO THE DEVICE¿S EXTERNAL PACKAGING. THE BOX THAT THE DEVICES CAME IN WAS NOT DAMAGED/BROKEN. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER WAS NOT REPAIRED, IT WAS TAKEN FROM THE PACKAGE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO REMEDIAL ACTION WAS PERFORMED; NO OTHER PRODUCT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273892 ↗

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-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-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-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-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-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
• 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-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-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

…and 33 more.