MAHURKAR 8888145001Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10884521014084), received between Jul 11, 2017 and Jul 28, 2025 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (11 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K111372); 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-1320-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT ARTERIOVENOUS (AV) FISTULA CREATION AND RECEIVED A CATHETER KIT FOR HEMODIALYSIS ACCESS ON (B)(6) 2025, DUE TO UREMIA AND USED IT FOR VASCULAR ACCESS TO FACILITATE HEMODIALYSIS TREATMENT. ON (B)(6) 2025 THE FIRST SESSION COMMENCED AND INITIALLY PROCEEDED SMOOTHLY. HOWEVER, AFTER 1 HOUR AND 40 MINUTES, THE CATHETER BLOOD DRAINAGE WAS VERY POOR, AND THE MACHINE FREQUENTLY ALARMED. HEMODIALYSIS TREATMENT COULD NOT BE PERFORMED, AND THE HEMODIALYSIS WAS TERMINATED EARLY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS REPAIRED. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH 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 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 22625790 ↗
• MalfunctionJul 25, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE SECOND DIALYSIS SESSION USING THE SAME CATHETER WAS PERFORMED ON (B)(6) 2025, WITH A PLANNED DURATION OF FOUR HOURS. DURING THE THIRD HOUR OF DIALYSIS, BLOOD FLOW DETERIORATED, TRIGGERING REPEATED MACHINE ALARMS. DESPITE MULTIPLE ADJUSTMENTS TO OPTIMIZE CATHETER POSITION AND BLOOD FLOW, THE CONDITIONS FOR EFFECTIVE HEMODIALYSIS WERE NOT MET. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. TEGO WAS NOT UTILIZED. ASIDE FROM THE REPORTED ISSUE, THERE WERE OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE SESSION WAS TERMINATED PREMATURELY AS A REMEDIAL ACTION. THE TREATMENT WAS NOT COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22608412 ↗
• MalfunctionJul 18, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, EARLY THE NEXT MORNING, BLEEDING RECURRED FROM THE CATHETER. EXAMINATION REVEALED A PINHOLE-LIKE CRACK IN THE CATHETER WALL WITH BLEEDING. THE UPPER SEGMENT OF THE CATHETER WAS CLAMPED TO CONTROL BLEEDING. ON (B)(6) THE CATHETER SEGMENT WAS REPLACED, AND NO FURTHER BLEEDING WAS OBSERVED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22542387 ↗
• MalfunctionJul 15, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE PATIENT HAD CHRONIC KIDNEY DISEASE AND WAS REGULARLY UNDERGOING HEMODIALYSIS AT THE HOSPITAL. ON (B)(6) 2025, A CATHETER KIT WAS IMPLANTED FOR VASCULAR ACCESS AND BLOOD WITHDRAWAL TO FACILITATE HEMODIALYSIS. THE FIRST USE OF THIS CATHETER OCCURRED ON (B)(6) 2025, FOR A SESSION THAT LASTED 1 HOUR AND 30 MINUTES. DURING THIS PROCEDURE, BLOOD FLOW THROUGH THE CATHETER WAS POOR, AND THE MACHINE FREQUENTLY ALARMED, PREVENTING CONTINUATION OF THE DIALYSIS, WHICH WAS TERMINATED EARLY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE AND WITH NORMAL RESULTS. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. 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 PATIENT'S MEDICATION REGIMEN INVOLVED AN INITIAL DOSE OF 10 MG OF HEPARIN ADMINISTERED VIA ARTERIAL INJECTION, FOLLOWED BY CONTINUOUS ARTERIAL INFUSION AT A RATE OF 3.5 MG/HOUR. THE TOTAL DOSAGE ADMINISTERED OVER THE COURSE OF TREATMENT WAS 10.5 MG, AS THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. ASIDE FRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22515580 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, THE CATHETER WAS USED FOR A SECOND DIALYSIS SESSION. DESPITE ADJUSTMENTS, BLOOD FLOW REMAINED INADEQUATE, AND THE MACHINE REPEATEDLY ALARMED, MAKING IT IMPOSSIBLE TO PERFORM EFFECTIVE DIALYSIS. AS A RESULT, THE PATIENT ONLY RECEIVED A BRIEF DIALYSIS SESSION, INSUFFICIENT FOR ADEQUATE TREATMENT. THE DIALYSIS WAS PREMATURELY TERMINATED, SHORTENING THE SESSION DURATION AND AUTOGENOUS ARTERIOVENOUS FISTULA WAS PLANNED AS AN ALTERNATIVE VASCULAR ACCESS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22515267 ↗
• MalfunctionJul 14, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED TO THE NEPHROLOGY WARD OF THE HOSPITAL ON (B)(6) 2025, AT 15:24:09, DUE TO STAGE 5 CHRONIC KIDNEY DISEASE. FOLLOWING ADMISSION, A CHRONIC CATHETER WAS PLACED FOR HEMODIALYSIS, AND THE CATHETER WAS REGULARLY REPLACED DURING THE HOSPITAL STAY. ON THE DAY OF THE EVENT AT 16:50:00, THE PATIENT'S FAMILY REPORTED THE SUDDEN APPEARANCE OF MINOR BLOOD EXTRAVASATION AT THE VENOUS END OF THE DIALYSIS CATHETER WITHOUT ANY APPARENT TRIGGER. THE NURSE INSPECTED THE CATHETER AND FOUND NO OBVIOUS CRACKS; AFTER SEALING AND DRESSING THE CATHETER, NO FURTHER BLEEDING WAS OBSERVED. HOWEVER, EARLY THE NEXT MORNING, BLEEDING RECURRED FROM THE CATHETER. EXAMINATION REVEALED A PINHOLE-LIKE CRACK IN THE CATHETER WALL WITH BLEEDING. THE UPPER SEGMENT OF THE CATHETER WAS CLAMPED TO CONTROL BLEEDING. ON (B)(6), THE CATHETER SEGMENT WAS REPLACED, AND NO FURTHER BLEEDING WAS OBSERVED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494566 ↗
• MalfunctionJun 23, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN OPENING THE OUTER POUCH, IT WAS FOUND THAT THE SILICONE CONNECTION AT THE VENOUS END WAS BROKEN. THE CATHETER WAS NOT REPAIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311208 ↗
• MalfunctionMar 19, 2025Break; Break

  ACCORDING TO THE REPORTER, FOUR MONTHS AFTER THE CATHETER WAS IMPLANTED, DURING HEMODIALYSIS (HD) DIALYSIS TREATMENT, A CRACK WAS OBSERVED IN THE BLUE (VENOUS) ADAPTER. IT WAS ALSO MENTIONED THAT THERE WAS A LEAK AT THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT WHERE THE LEAKAGE WAS OBSERVED. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE, AND TEGO WAS NOT UTILIZED. FLUSHING WAS PERFORMED, AND THE RESULT OF FLUSHING WAS NORMAL. NO OTHER PRODUCT WAS UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS APPLIED. MAUKANG IODOVO DISINFECTION WAS USED AS A CLEANING AGENT ON THE DEVICE, WHILE MAEKON IODINE VASE DISINFECTION WAS USED TO CLEAN THE CONNECTORS. THESE CLEANING AGENTS WERE THOROUGHLY DRIED BEFORE APPLYING THE MEDICATED CREAM TO THE AREA. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION, DIALYSIS WITH AUTOLOGOUS ARTERIOVENOUS FISTULA (AVF) WAS PERFORMED, AND THE REPORTED DEVICE WAS REMOVED AS REQUIRED INTERVENTION DUE TO THE EVENT. THE TRE ATMENT WAS NOT COMPLETED. THE REPORTED CATHETER WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT. THERE WAS A LITTLE (UNKNOWN) AMOUNT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642491 ↗
• MalfunctionMar 3, 2025Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED ON (B)(6) 2024. AFTER MORE THAN TWO MONTHS OF USE, A CRACK WAS FOUND ON THE BLUE (VENOUS) LUER CONNECTOR. THE REPORTED PRODUCT WAS REMOVED FROM THE PATIENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS DONE, AND NO ABNORMALITY WAS OBSERVED. THERE WAS A LEAK. THE TEGO WAS NOT UTILIZED. THE CLEANING AGENT USED WAS MAOKANG IODINE SOLUTION. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED, AND A REPAIR KIT WAS NOT USED. ASIDE FROM THE CRACK, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED WITH ANOTHER BRAND TUBE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501993 ↗
• MalfunctionMar 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE, IT WAS FOUND THAT THE BLUE (VENOUS) LUER ADAPTER WAS CRACKED AND HAD A LEAK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NO ABNORMALITY. THE CATHETER WAS NOT REPAIRED, AND TEGO WAS NOT UTILIZED. IODOPHOR LIQUID WAS THE CLEANING AGENT USED ON THE DEVICE. 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 USE ON THE DEVICE, AND NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. 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 BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THE REPORTED PRODUCT WAS REPLACED AS A REMEDIAL ACTION DONE, AND INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501970 ↗
• MalfunctionJan 16, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, A SEMI-PERMANENT HEMODIALYSIS CATHETER CATHETERIZATION PROCEDURE WAS PERFORMED FOR THE RIGHT INTERNAL JUGULAR VEIN, WHEN THE CATHETER WAS USED FOR BLOOD PURIFICATION TREATMENT, IT WAS FOUND THAT THE FLOW RATE OF THE CATHETER WAS POOR IN THE POSITIVE CONNECTION, AND THE FLOW RATE WAS POOR AFTER THE RETURN CONNECTION. THE DIALYSIS MACHINE REPEATEDLY ALERTED THE VENOUSPRESSURE, AND THE CATHETER WAS ADJUSTED SEVERAL TIMES, AND THE BLOOD PURIFICATION COULD BE CONTINUED AT A LOW FLOW RATE. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. AFTER THE NEW TUBE WAS INSERTED, THE CATHETER WAS ADJUSTED REPEATEDLY, AND THE DIALYSIS TREATMENT WAS NOT SMOOTH. THE ADJUSTMENT OF THE TUBE CAUSES PAIN IN THE PATIENT, AND THE REPEATED VENOUS PRESSURE ALARM OF THE DIALYSIS MACHINE, AND THE PATIENT WAS OLDER, WHICH MAY CAUSE TENSION AND ANXIETY DURING TREATMENT, WHICH MAY AFFECT THE TREATMENT EFFECT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168962 ↗
• MalfunctionJan 13, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE DEPARTMENT BEGAN USING THE SEMI-PERMANENT HEMODIALYSIS CATHETER¿CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS. AFTER CATHETER REPLACEMENT, THE PATIENT'S ARTERIOVENOUS SUCTION FLOW WAS POOR AND EASILY STUCK TO THE BLOOD VESSEL WALL, RESULTING IN INSUFFICIENT HEMODIALYSIS FLOW. THE CURRENT USAGE SHOWED A POSITIVE FLOW. THE CATHETER FLOW DIFFERENCE AND THE CATHETER ADJUSTMENT SITUATION HAVE BEEN REFLECTED IN THE COURSE OF DISEASE AND DIALYSIS RECORDS. THE CATHETER DEPTH WAS AT THE TIP FLAT TH8 LOWER BORDER. THE DIALYSIS MACHINE REPEATEDLY ALARMED, MAKING IT DIFFICULT TO PERFORM HEMODIALYSIS. THE INCIDENCE OF CATHETER FLOW DIFFERENCE WAS AS HIGH AS 71.43%. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21140043 ↗
• MalfunctionJan 13, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE DEPARTMENT BEGAN USING THE SEMI-PERMANENT HEMODIALYSIS CATHETER¿CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS. AFTER CATHETER REPLACEMENT, THE PATIENT'S ARTERIOVENOUS SUCTION FLOW WAS POOR AND EASILY STUCK TO THE BLOOD VESSEL WALL, RESULTING IN INSUFFICIENT HEMODIALYSIS FLOW. THE CURRENT USAGE SHOWED A POSITIVE FLOW. THE CATHETER FLOW DIFFERENCE AND THE CATHETER ADJUSTMENT SITUATION HAVE BEEN REFLECTED IN THE COURSE OF DISEASE AND DIALYSIS RECORDS. THE CATHETER DEPTH WAS AT THE TIP-TO-T10 LEVEL. THE DIALYSIS MACHINE REPEATEDLY ALARMED, MAKING IT DIFFICULT TO PERFORM HEMODIALYSIS. THE INCIDENCE OF CATHETER FLOW DIFFERENCE WAS AS HIGH AS 71.43%. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21139775 ↗
• MalfunctionJan 13, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE DEPARTMENT BEGAN USING THE SEMI-PERMANENT HEMODIALYSIS CATHETER¿CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS. AFTER CATHETER REPLACEMENT, THE PATIENT'S ARTERIOVENOUS SUCTION FLOW WAS POOR AND EASILY STUCK TO THE BLOOD VESSEL WALL, RESULTING IN INSUFFICIENT HEMODIALYSIS FLOW. THE USER NOTICED THE INSUFFICIENT FLOW AT THE FIRST USE AFTER CATHETERIZATION. THE CURRENT REVERSE FLOW WAS WORSE AND THE FORWARD FLOW WAS NOT GOOD. THE CATHETER FLOW DIFFERENCE AND THE CATHETER ADJUSTMENT SITUATION WERE REFLECTED IN THE COURSE OF DISEASE AND DIALYSIS RECORDS. THE CATHETER DR CHEST RADIOGRAPH CATHETER DEPTH WAS APPROXIMATELY AT THE LEVEL OF THE TH10 ORIFICE. THE DIALYSIS MACHINE REPEATEDLY ALARMED, MAKING IT DIFFICULT TO PERFORM HEMODIALYSIS. THE INCIDENCE OF CATHETER FLOW DIFFERENCE WAS AS HIGH AS 71.43%. THIS WAS NOT THE INFUSION LINE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND NO OTHER DAMAGE WAS FOUND ON THE PRODUCT. THERE WAS NO PROBLEM WITH THE LUER ADAPTER, THERE WAS NO LEAK, AND THE CATHETER WAS N OT REPAIRED BUT WAS USED RELUCTANTLY. TEGO WAS NOT USED, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS PERFORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138960 ↗
• MalfunctionJan 13, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE DEPARTMENT BEGAN USING THE SEMI-PERMANENT HEMODIALYSIS CATHETER-CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS. AFTER THE CATHETER REPLACEMENT, THE PATIENT'S ARTERIOVENOUS SUCTION FLOW WAS POOR AND EASILY ADHERED TO THE BLOOD VESSEL WALL, RESULTING IN INSUFFICIENT HEMODIALYSIS FLOW. THE USER NOTICED THE INSUFFICIENT FLOW DURING THE FIRST USE AFTER CATHETERIZATION. THE CATHETER HAD POOR REVERSE FLOW. IT WAS NOT THE INFUSION LINE. THE CATHETER FLOW DIFFERENCE AND THE CATHETER ADJUSTMENT SITUATION WERE REFLECTED IN THE MEDICAL HISTORY AND DIALYSIS RECORDS. THE CATHETER DEPTH ON THE DR CHEST X-RAY WAS AT THE TIP OF THE RIGHT VERTEBRAL MARGIN. THE DIALYSIS MACHINE REPEATEDLY ALARMED, MAKING IT DIFFICULT TO PERFORM HEMODIALYSIS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DAMAGE TO THE PRODUCT WAS FOUND. THERE WAS NO PROBLEM WITH THE LUER ADAPTER AND THERE WAS NO LEAK. THE CATHETER WAS USED RELUCTANTLY. TEGO WAS NOT USED AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. FL USHING WAS PERFORMED AND THE LINE WAS NOT DIFFICULT TO FLUSH WITH THE SYRINGE AND THE CATHETER WAS INTACT AS A RESULT. THERE WAS NO BLOOD RETURN

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

  MAUDE report 21138721 ↗
• MalfunctionJan 13, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE DEPARTMENT BEGAN USING THE SEMI-PERMANENT HEMODIALYSIS CATHETER - CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS. AFTER THE CATHETER REPLACEMENT, THE PATIENT'S ARTERIOVENOUS SUCTION FLOW WAS POOR AND EASILY STUCK TO THE BLOOD VESSEL WALL, RESULTING IN INSUFFICIENT HEMODIALYSIS FLOW. THE USER NOTICED THE INSUFFICIENT FLOW AT THE FIRST USE AFTER CATHETERIZATION. THE CURRENT USE DID NOT ALLOW FOR POSITIVE AND NEGATIVE FLOW. THE CATHETER FLOW DIFFERENCE AND THE CATHETER ADJUSTMENT SITUATION WERE REFLECTED IN THE DISEASE HISTORY AND DIALYSIS RECORDS. THE DR CHEST RADIOGRAPH CATHETER DEPTH WAS AT THE LEVEL OF THE 9TH VERTEBRAL BODY AT THE END OF THE CATHETER. THE DIALYSIS MACHINE REPEATEDLY ALARMED, MAKING IT DIFFICULT TO PERFORM HEMODIALYSIS. THE INCIDENCE OF CATHETER FLOW DIFFERENCE WAS AS HIGH AS 71.43%. THE REVERSE FLOW RATE OF 180-200ML/MIN WAS HARDLY USABLE. THIS WAS NOT THE INFUSION LINE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND NO OTHER DAMAGE WAS FOUND ON THE PRODUCT. THERE WAS NO PROBLEM WITH THE LUER ADAPTER, THERE WAS NO LEAK, AND THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT USED AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138647 ↗
• MalfunctionJan 13, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE DEPARTMENT BEGAN USING THE SEMI-PERMANENT HEMODIALYSIS CATHETER - CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS. AFTER THE CATHETER REPLACEMENT, THE PATIENT'S ARTERIOVENOUS SUCTION FLOW WAS POOR AND EASILY STUCK TO THE BLOOD VESSEL WALL, RESULTING IN INSUFFICIENT HEMODIALYSIS FLOW. THE CATHETER HAD POOR FLOW IN BOTH FORWARD AND REVERSE FLOW. THE CATHETER FLOW DIFFERENCE AND THE CATHETER ADJUSTMENT SITUATION WERE REFLECTED IN THE DISEASE COURSE AND DIALYSIS RECORDS. THE CATHETER DEPTH ON THE DR CHEST X-RAY WAS AT THE LEVEL OF THE LOWER EDGE OF THE T9 LEVEL VERTEBRA AT THE END OF THE CATHETER. THE DIALYSIS MACHINE REPEATEDLY ALARMED, MAKING IT DIFFICULT TO PERFORM HEMODIALYSIS. THE INCIDENCE OF CATHETER FLOW DIFFERENCE WAS AS HIGH AS 71.43%. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE BEFORE USE AND NO OTHER DAMAGE WAS FOUND ON THE PRODUCT. THERE WERE NO PROBLEMS WITH THE LUER ADAPTER AND NO LEAKS. THE CATHETER WAS USED RELUCTANTLY. TEGO WAS NOT USED AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS PERFORMED AND THE LINE WAS NOT DIFFICULT TO FLUSH WITH THE SYRINGE AND THE CATHETER WAS INTACT AS A RESULT. THERE WA S NO BLOOD

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

  MAUDE report 21138338 ↗
• MalfunctionJan 9, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER THE PATIENT HAD STAGE 5 CHRONIC KIDNEY DISEASE AND NEEDED LONG-TERM HEMODIALYSIS TREATMENT. AFTER A SEMI-PERMANENT HEMODIALYSIS CATHETER WAS PLACED AS A VASCULAR ACCESS, IT WAS FOUND THAT THE BLOOD FLOW OF THE SEMI-PERMANENT HEMODIALYSIS CATHETER WAS NOT SMOOTH AND POOR. AS PRELIMINARY ACTIONS, THEY OBSERVED THE PATIENT'S CATHETER PLACEMENT AND ADJUSTED THE POSITION OF THE CATHETER REPEATEDLY SO BLOOD FLOW COULD BE SMOOTH, AND THEY REPORTED THE EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21110254 ↗
• MalfunctionMar 1, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED SUCCESSFULLY LAST (B)(6) 2022, AND GOOD BACK FLOW WAS OBSERVED. THREE DAYS LATER, DURING MAINTENANCE DIALYSIS, LEAKAGE WAS OBSERVED AT THE JUNCTION OF THE EXTENSION TUBE AND BIFURCATE, AND SO THE DIALYSIS SESSION WAS STOPPED IMMEDIATELY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED, THE CLEANING AGENT USED ON THE DEVICE WERE BETADINE, CHLORHEXIDINE AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. IT WAS STATED THAT THE PATIENT WAS SHIFTED TO THE CATHETERIZATION LABORATORY (CATH LAB) AND A NEW CATHETER WITH A SIMILAR MODEL NUMBER WAS INSERTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. GOOD BACK FLOW WAS OBSERVED ON THE NEW CATHETER AND THE PATIENT DIALYSIS SESSION WAS SUCCESSFULLY COMPLETED. THERE WAS A BLOOD LOSS OF 2 ML. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637082 ↗
• MalfunctionOct 6, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS INSERTED TO THE PATIENT AND HAD A FOLLOW UP FOR DIALYSIS TREATMENT. WHEN THE DIALYSIS TECHNICIAN WAS CONNECTING THE SYRINGE BEFORE THE BLOODLINES WERE CONNECTED, IT WAS FOUND THAT THE RED (ARTERIAL) ADAPTER HAD A CRACK OR IT WAS BROKEN PRIOR TO USE. AFTER THE EVENT, THE PATIENT WAS ADVISED TO CHANGE THE CATHETER WITH A NEW ONE. THE TREATMENT WAS COMPLETED, THERE WAS A BLOOD LEAK AND BLOOD TRANSFUSION WAS NOT REQUIRED. FLUSHING WAS PERFORMED AND THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE. BETADINE WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT AND AS THE CLEANING AGENT TO CLEAN THE ADAPTERS. THE CATHETER THAT CAME WITH THE KIT WAS THE ONE USED, THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT, THE DOCTOR CHANGED THE CATHETER AFTER IT WAS REPAIRED INITIALLY, BETADINE WAS USED AS THE CLEANING AGENT ON THE DEVICE, TEGO WAS UTILIZED, AN INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 12583927 ↗
• MalfunctionJul 7, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, A RUPTURE OCCURRED AT THE JUNCTION OF THE VENOUS (BLUE) SILICONE EXTENSION TUBE AND THE CATHETER BODY (BIFURCATE). THEY PULLED OUT AND REPLACED WITH A NEW SET TO RESOLVED THE ISSUE. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED. FLUSHING WAS DONE PRIOR TO USE. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER WAS NOT REPAIRED, NO TEGO WAS UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. NORMAL SALINE WAS THE CLEANING AGENT USED ON THE DEVICE AND TO CLEAN THE ADAPTERS. IODOPHOR AND SALINE WERE THE CLEANING AGENTS USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. IT WAS STATED THAT THE CLAMPS WERE CLAMPS MOVED TO A NEW LOCATION AFTER EACH TREATMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131182 ↗
• MalfunctionJun 28, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE INSERTION PROCEDURE, THE PRODUCT WAS DEFECTIVE (BLOCKED IN ONE LUMEN). THE CATHETER WAS NOT REPAIRED AND 2% CHLOROHEXIDINE WAS USED AS THE CLEANING AGENT ON THE DEVICE. TEGO WAS UTILIZED. THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. AN UNKNOWN SOLUTION WAS USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS NOT DONE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES. THERE WAS NO BLOOD LOSS. THE PRODUCT WAS REPLACED IMMEDIATELY WITH A NEW ONE FROM THE HOSPITAL'S STOCK TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080278 ↗
• MalfunctionJun 25, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, ON THE DAY OF THE CATHETER INSERTION (POST INSERTION), DURING A NORMAL HEMODIALYSIS SESSION, MACHINE (COMPETITOR'S BRAND) ALARMS ACTIVATED AND THERE WAS NO BLOOD FLOW. IT WAS STATED THAT THE CATHETER WAS OCCLUDED ON THE CATHETER TIP AND MAY BE DUE TO A THROMBOSIS. THE CUSTOMER TRIED TO REVERSE THE LINES AND THE REVERSE FLOW WAS SUCCESSFUL BUT ONLY FOR SOME TIME. AGAIN, THE MACHINE HAD THE ALARM. ON THE NEXT DAY, THE CATHETER WAS REMOVED AND REPLACED WITH THE SAME BRAND (SAME LOT). THE NEW DEVICE WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THERE WAS BLOOD RETURN PRIOR TO SYRINGE FLUSH AND IT WAS MENTIONED THAT THE LINE WAS NOT HARD TO FLUSH. THIS WAS NOT THE INFUSION LINE. NO ANTI-COAGULANT USED. FLUSHING WAS DONE SUCCESSFULLY PRIOR TO USE BOTH TO THE CATHETER AND REPLACEMENT CATHETER. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065581 ↗
• MalfunctionFeb 25, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN THE CENTRAL VENOUS CATHETER WAS INSERTED INTO THE PATIENT FOR HEMODIALYSIS TO TREAT UREMIA, THE MEDICAL STAFF FOUND THAT THE PUNCTURE NEEDLE AND THE GUIDE WIRE WERE INCARCERATED OR STUCK MAKING IT UNUSABLE. AT THE SAME TIME, THE GUIDE WIRE AND THE PUNCTURE NEEDLE WERE PULLED OUT, BUT THEY STILL COULD NOT BE SEPARATED OUTSIDE THE BODY, AND THEN REPLACED WITH A NEW CATHETER. IT WAS REPORTED THAT THE INCIDENT HAD A RISK OF INFECTION AND THE PATIENT HAD TISSUE DAMAGE. IT WAS LATER REPORTED THAT NO ADVERSE EVENT OCCURRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11379605 ↗
• MalfunctionDec 2, 2020Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS GIVEN AN INDWELLING CENTRAL VENOUS CATHETER SET TO ESTABLISH A VASCULAR ACCESS FOR HEMODIALYSIS TREATMENT FOR A LONG PERIOD OF TIME AS THE PATIENT WAS UNABLE TO ESTABLISH AN ARTERIOVENOUS INTERNAL FISTULA. DURING THE SURGERY, VENOUS LEAKAGE WAS FOUND AT THE VENOUS END (AT THE CLOSED CLIP OF THE TRANSPARENT EPITAXIAL TUBE CONNECTED TO THE JOINTER, NEAR THE ADAPTER). THERE WAS NO COMBINED MEDICATION/DEVICE. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE AND ON THE ADAPTERS. TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. DISINFECTION USING ANER IODINE WAS PERFORMED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE CLAMP WAS NOT MOVED PERIODICALLY, AND NORMAL SLIGHT ROTATION WAS UTILIZED TO TIGHTEN THE ADAPTERS. THERE WAS NO OINTMENT USED OR APPLIED TO THE AREA. THERE WAS NO DAMAGE TO THE DEVICE'S BOX AND PACKAGING. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE, BUT IT WAS NOT KNOWN WHETHER THE TUBE WAS LEAKING. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. IT WAS NOT CHECKED CAREFULLY WHETHER THERE WERE OTHER DEFECTS/DAMAGES FOUND ON THE PROD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10933857 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1316-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.