MAHURKAR 8888135132Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521006218), received between Feb 7, 2019 and Jun 23, 2025 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 reports).

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

9 other recalls cover devices cleared under the same FDA submission (K030209, K192302); 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. Dec 7, 2022Class IOpen, Classified

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

   Z-0877-2023 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING USE ON THE PATIENT, THE GUIDEWIRE RELEASED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE, AND THE RESULT WAS NORMAL. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. ROUTINE STERILIZATION AND LOCAL ANESTHESIA, WAS THE INSERTION SITE TREATED PRIOR TO PRODUCT PLACEMENT? THERE WERE NO TOOLS USED WHEN TRYING TO REMOVE THE GUIDEWIRE. THERE WAS NO RESISTANCE WHEN INSERTING THE GUIDEWIRE. 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. AS A REMEDIAL ACTION, IT WAS REPLACED WITH A SET OF TUBING. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION. 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 22310846 ↗
• MalfunctionJun 19, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE PHYSICIAN PERFORMED A RIGHT INTERNAL JUGULAR VEIN CATHETERIZATION. THE INITIAL GUIDEWIRE INSERTION WAS DIFFICULT. UPON REMOVAL, THE GUIDEWIRE WAS FOUND TO BE KINKED AND SPLIT. THERE WAS RESISTANCE WHEN INSERTING THE GUIDEWIRE. AS A REMEDIAL ACTION AND INTERVENTION, THE CATHETER WAS REPLACED. THE PROCEDURE WAS REPEATED AND COMPLETED AFTER THE REMEDIAL ACTION. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. 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 22289605 ↗
• MalfunctionJan 13, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT WAS UNDERGOING BEDSIDE DIALYSIS. DURING THE INSPECTION, THE CIRCULATING NURSE FOUND THAT THE BLOOD RETURN END OF THE HEMODIALYSIS CATHETER WAS CRACKED, AND THE HEMODIALYSIS CATHETER WAS REPLACED IMMEDIATELY. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 21137754 ↗
• MalfunctionNov 11, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE GUIDEWIRE PROVIDED WITH THE KIT COULD NOT BE PULLED OUT DURING CATHETER PLACEMENT. THEY MENTIONED THAT IT COULD BE A PRODUCT QUALITY ISSUE. IT WAS ALSO MENTIONED THAT IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY DUE TO THE DEFECT. WHEN REMOVED, IT SHOWED THAT THE GUIDEWIRE WAS STILL INTACT (DID NOT BREAK APART). THERE WAS NOTHING ELSE NOTED PRIOR TO USE, AND BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DAMAGES FOUND ON THE PRODUCT. THERE WAS NO LEAK, AND THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NO EXCESSIVE FORCE USED, AND THE GUIDEWIRE WAS REMOVED BY HAND. AS A REMEDIAL ACTION, THEY UNPACKED A NEW SET OF CATHETER FROM THE SAME PRODUCT ID WITH A DIFFERENT LOT AND USED ON THE SAME DAY, AND THE PROCEDURE WAS COMPLETED. NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THE EVENT, AND THE PATIENT WAS IN GOOD CONDITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652618 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO LIVER FAILURE, AND A HEMOFILTRATION CATHETER WAS INSERTED INTO THE INTERNAL JUGULAR VEIN ON (B)(6) 2022. AND ON (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, AND (B)(6) 2022, THE HEMOFILTER CATHETER WAS USED FOR ARTIFICIAL LIVER TREATMENT/ARTIFICIAL LIVER THERAPY FOUR (4) TIMES FOR LIVER FAILURE. AFTERWARDS, THE PATIENT DEVELOPED PERSISTENT FEVER, THE CATHETER WAS THEN REMOVED AND CULTURED. IT WAS MENTIONED THAT STAPHYLOCOCCUS WAS CULTURED, AND IT WAS CONSIDERED AS CATHETER INFECTION. IT WAS STATED THAT THE PATIENT HAD SYMPTOMS OF ALCOHOL WITHDRAWAL, AND WAS UNCONSCIOUS, AND REMOVED DRESSING FREQUENTLY. THERE WAS NO COMBINED MEDICATION/DEVICE AND THERE WAS NO DEVICE MALFUNCTION. THE PATIENT WAS CURED FROM BACTERIAL INFECTION AFTER ANTI-INFECTIVE/ANTIBIOTIC TREATMENT WAS GIVEN.

  Patient problems: Bacterial Infection; Fever

  MAUDE report 15797930 ↗
• MalfunctionSep 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THEY OPENED THE PACKAGE OF THE CATHETER AND PUNCTURED THE VESSEL WITH THE NEEDLE. WHEN PREPARING TO USE THE CATHETER, IT WAS FOUND THAT THE BLUE LUER CONNECTOR OF THE CATHETER WAS DETACHED/SEPARATED, DROPPED AND UNUSABLE. NO DAMAGE WAS NOTED ON THE DEVICE PACKAGING. THE BOX THAT THE DEVICE CAME IN WAS INTACT. ASIDE FROM THE SEPARATED LUER CONNECTOR, THERE WAS NO OTHER UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE DEVICE WAS NOT REPAIRED. FLUSHING WAS DONE PRIOR TO USE WITH NORMAL RESULTS. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. IT WAS SAID THAT THE PROCEDURE WAS TERMINATED BY RUSHING THE NEEDLE WITHDRAWAL AND A SET OF NEW CATHETER WAS TAKEN AGAIN TO RESOLVE THE ISSUE. THE PROCEDURE WAS THEN CONTINUED AND COMPLETED. THERE WAS 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 15521446 ↗
• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE PACKAGING WAS OPENED, BLOOD VESSEL HAD BEEN PUNCTURED WITH THE NEEDLE AND WHEN PREPARING TO USE THE CATHETER (ABOUT TO USE THE TUBE), IT WAS FOUND THAT THE VENOUS (BLUE) LUER ADAPTER HAD FALLEN OFF (DROPPED) THEN THE NEEDLE WAS REMOVED TO TERMINATE THE OPERATION. THERE WAS NO EXCESSIVE FORCE USED ON THE PRODUCT, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS NOT PERFORMED. DURING THE PROCESS, 2 HEPARIN CAPS WERE SATURATED WITH BLOOD. THE CATHETER WAS NOT REPAIRED. A NEW SET OF TUBE WAS TAKEN TO CONTINUE THE OPERATION WHICH PROCEEDED TO TREATMENT AND IT WAS COMPLETED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO BLOOD LOSS. THERE WAS 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 15372755 ↗
• MalfunctionJun 21, 2022Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE CATHETER PLACEMENT, THE GUIDE WIRE TIP WAS BENT IN THE CATHETER AND COULD NOT BE SMOOTHLY LOWERED TO THE SITE. IT WAS ALSO MENTIONED THAT WHEN THEY WERE OPENING THE PACKAGE, THE SURGEON OBSERVED THAT THE TIP OF THE GUIDE WIRE WAS BENT BUT STILL TRIED TO DELIVER, BUT IT WAS UNSUCCESSFUL. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE AND THERE WAS NO LUER ADAPTER ISSUE. IODOPHOR AND SALINE WERE THE CLEANING AGENTS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT AND NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO INSERTION AND IT WENT WELL. THERE WAS NO OCCLUSION. IT WAS STATED THAT THE GUIDE WIRE WAS NEEDED TO BE TAKEN OUT TOGETHER WITH THE CATHETER IN ONE ACTION AND IT WAS REMOVED DIRECTLY BY HAND. THERE WAS NO EXCESSIVE FORCED USED ON INSERTION AND WITHDRAWAL OF THE GUIDE WIRE. THE GUIDE WI RE WAS STILL INTACT WHEN IT WAS REMOVED. A NEW CATHETER SET WAS OPENED AND RE-IMPLANTED. AFTERWARDS, THE PATIENT WAS SUCCESSFULLY DISPLACED AFTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754999 ↗
• MalfunctionMay 7, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING PRE-OPERATIVE EXAMINATION OF THE OPEN PACKAGE, IT WAS FOUND THAT THERE WAS A SMALL HOLE IN THE MIDDLE OF THE VENOUS EXTENSION TUBE NEAR THE CLAMP AND HAD A LEAK. THE CATHETER WAS NOT REPAIRED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317464 ↗
• InjuryNov 8, 2021Obstruction of Flow; Infusion or Flow Problem; Material Integrity Problem; Obstruction of Flow; Infusion or Flow Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, AT 14:00 ON (B)(6) 2021, THE PATIENT CAME TO THE HOSPITAL FOR DIALYSIS DUE TO UREMIA. THE CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS WAS PLACED UNDER THE GUIDANCE OF COLOR DOPPLER ULTRASOUND. DURING THIS PERIOD, THE PROFESSIONAL PERFORMED NORMAL OPERATIONS AND THE POSITION FOR CATHETER PLACEMENT WAS SUCCESSFULLY LOCATED UNDER THE GUIDANCE OF COLOR DOPPLER ULTRASOUND. RESISTANCE WAS FELT DURING RETENTION WITH THE GUIDE WIRE. AFTER IT WAS RETREATED AND ENTERED AGAIN, THE RESISTANCE WAS FELT TO BE DISAPPEARED. THE COLOR DOPPLER ULTRASOUND CONFIRMED THAT THE CATHETER ON THE DIALYSIS MACHINE WAS NOT ABLE TO DRAW BLOOD SMOOTHLY AND THE VENOUS BLOOD DID NOT RETURN. THE CHEST RADIOGRAPH INSPECTION WAS PERFORMED IMMEDIATELY FOR THE PATIENT. THE REPORT SHOWED THAT THE TIP OF THE CATHETER WAS TURNED/FOLDED BACK, RESULTING IN INABILITY TO DRAW BLOOD SMOOTHLY AND PERFORM DIALYSIS. IT WAS COMMUNICATED WITH THE PATIENT TO MAKE AN APPOINTMENT WITH COLOR DOPPLER ULTRASOUND TO ADJUST THE POSITION ON A FUTURE DATE, IF THE ADJUSTMENT FAILED, A NEW CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS WILL BE USED IN ANOTHER POSITION. NOTHING UNUSUAL OBSERVED PRIOR TO PROCEDURE. THE

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12769330 ↗
• MalfunctionAug 12, 2021Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT FOR TEMPORARY CATHETERIZATION OF THE RIGHT INTERNAL JUGULAR VEIN ON (B)(6) 2021, AND THE PROCESS WENT SMOOTHLY. WHEN CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) WAS PERFORMED ON (B)(6) 2021, THE CATHETER WAS FOUND TO BE DAMAGED DURING THE PROCESS. THERE WAS NO LEAKAGE AT THE PRESENT, AND HEMODIALYSIS WAS NOT AFFECTED TEMPORARILY. THEY CONTINUED THE TREATMENT TEMPORARILY, AND CHOOSE THE OTHER DAY FOR A LONG-TERM CATHETER INSERTION AS A LONG-TERM HEMODIALYSIS PATHWAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314060 ↗
• MalfunctionMay 6, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE GUIDE WIRE OF THE TEMPORARY INTERNAL CAROTID TUBE WAS STUCK IN THE PUNCTURE NEEDLE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE PUNCTURE NEEDLE AND THE GUIDE WIRE WERE WITHDRAWN TOGETHER. AFTER REMOVAL, THE GUIDE WIRE HEAD WAS BENT. THE BENT IN THE GUIDE WIRE WAS NOT NOTICED IN THE PACKAGING. NO RESISTANCE WAS USED WHEN INSERTING THE GUIDE WIRE. THEY PULLED OUT THE PUNCTURE NEEDLE AND GUIDE WIRE WITH A LITTLE FORCE. NO TOOLS WERE USED TO REMOVE THE GUIDE WIRE. NO VISIBLE DEFECTS/DAMAGES FOUND IN THE NEEDLE. THE GUIDE WIRE AND NEEDLE INCLUDED IN THE KIT WERE THE ONES USED. THE DIMENSION OF THE NEEDLE AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO ABNORMALITY FOUND DURING FLUSHING. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE INSERTION SITE WAS CLEANED AND DISINFECTED. THERE WAS NO BLOOD LOSS. A NEW SET OF THE SAME BRAND WAS USED AND THE PUNCTURE WAS PERFORMED AGAIN ON THE DAY OF OPERATION. THE PROCEDURE WAS COMPLETED. NO O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783263 ↗
• MalfunctionJul 31, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING USE, THE BLUE LUER ADAPTER/CONNECTOR WAS SPLIT/CRACKED. SALINE WAS USED TO CLEAN THE ADAPTERS. NO OINTMENTS WAS USED. NO OTHER PRODUCTS WAS BEING UTILIZED WITH THE DEVICE. CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, SALINE/ALCOHOL WAS THE CLEANING AGENT USED. TEGO WAS NOT UTILIZED. IT WAS STATED THAT THE DEVICE WAS STERILIZED ACCORDING TO SPECIFICATIONS. NOTHING UNUSUAL WAS OBSERVED PRIOR TO USE. THE CATHETER CONNECTOR WAS REPLACED TO RESOLVE THE ISSUE. NO INTERVENTION OR TREATMENT WAS REQUIRED, NO BLOOD LOSS WAS REPORTED. NORMAL DIALYSIS WAS DONE, AND PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10351329 ↗
• MalfunctionJul 27, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, ON MAY 2020 THE PATIENT WAS IMPLANTED WITH CENTRAL VENOUS CATHETER FOR HEMODIALYSIS,FLUSHING WAS DONE PRIOR TO USE (FROM MORE THAN A MONTH OF USE), IT WAS STATED THAT THE A CRACK AT THE JUNCTION OF THE VENOUS END WAS NOTED DURING USE AND BLOOD LEAKED, IT WAS STATED THAT THEY TIGHTEN THE ADAPTERS BY HAND. THE NURSE PROMPTLY FOUND IT AND REPLACED THE CONNECTION JOINT IMMEDIATELY. PHYSIOLOGICAL SALINE WAS USED TO CLEAN THE DEVICE. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE PROCEDURE WAS COMPLETED. IT WAS SAID THAT THE ONLY THE CONNECTION JOINT OF CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10326419 ↗
• MalfunctionMar 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CATHETER'S TIP (TUBE HEAD) HAD PROLAPSED DURING CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY). THE CATHETER WAS NOT REPAIRED AND THERE WAS A LEAK AT THE LUER CONNECTOR. NO CRACKS OBSERVED IN THE LUER JOINT AND IODOPHOR WAS USED AS CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THEY HAD TO REMOVED THE DEVICE TO RESOLVE THE ISSUE AND THE ADAPTERS WERE TIGHTEN BY HANDS. THE LEAK WAS LOCATED IN THE CATHETER FITTINGS AND EXTENSION TUBES (ARTERIAL SIDE). THERE WAS NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND NO MEDICAL INTERVENTION DONE TO THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9847253 ↗
• MalfunctionJul 2, 2019Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO RENAL FAILURE AND UNDERWENT CONTINUOUS RENAL REPLACEMENT THERAPY. AFTER THE SURGERY, THE RIGHT INGUINAL DIALYSIS CATHETER WAS PLACED AND THE PROCESS WAS SMOOTH. AFTER THE CATHETER WAS COMPLETELY PLACED, IT WAS FOUND TO BE RUPTURED AND IT WAS IMMEDIATELY REPLACED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8752970 ↗
• MalfunctionJun 27, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS A LEAKAGE FOUND ON THE TRANSPARENT SILICONE HOSE IN THE MIDDLE OF THE TUBE AND A HOLE WAS ALSO OBSERVED. THE CATHETER WAS NOT REPAIRED AND NO CLEANER WAS USED. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THEY HAD TO CHANGE THE TUBE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8742813 ↗
• MalfunctionFeb 25, 2019Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, CUSTOMER REPORTED THAT THE GUIDE WIRE THAT COMES WITH THE KIT WAS BROKEN AT DISTAL END AND THE CATHETER COULD NOT BE USED. IT WAS STATED THAT THE GUIDE WIRE WAS NOT BROKEN OUT OF THE BOX, THERE WAS NO PACKAGING DAMAGE, NO OTHER DEFECT/DAMAGE WAS NOTED TO THE GUIDE WIRE PRIOR TO USE. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO CLEANING AGENTS WERE USED, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8367762 ↗
• MalfunctionFeb 19, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PRIOR TO USE, ON PRESSURE FLUSHING, IT WAS REPORTED THAT A LEAK WAS NOTED IN THE MIDDLE SECTION OF THE TRANSPARENT SILICA TUBE. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, NO CLEANING AGENTS WERE USED, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8350726 ↗
• MalfunctionFeb 11, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, AFTER THAT CATHETER WAS IMPLANTED, BLOOD WAS FOUND TO BE LEAKING IN THE FROM THE BLUE TUBE (VENOUS) TRANSPARENT SILICONE HOSE AT THE JUNCTION DURING DIALYSIS. IT WAS STATED THAT THE CATHETER HAS BEEN IN PLACE FOR 3 MONTHS. IT WAS SATED THAT THE CATHETER WAS NOT REPAIRED, ANERDIAN WAS THE CLEANING AGENT USED, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS REPLACED. THERE WAS BLOOD LOSS OF 4ML. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8327289 ↗
• MalfunctionFeb 11, 2019Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PRIOR TO USE, ON INSPECTION OF THE PACKAGE, IT WAS FOUND THAT THERE WAS LEAKAGE IN THE PART OF THE TRANSPARENT SILICONE HOSE NEAR THE RED AND BLUE JOINTS. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT USED, AND THERE WAS NO LUER ADAPTER ISSUE. THERE ARE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 8325562 ↗
• MalfunctionFeb 7, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, CUSTOMER REPORTED A LEAK ON THE MIDDLE SECTION OF TRANSPARENT SILICONE HOSE OF THE VENOUS (BLUE) TUBE. IT WAS STATED THAT THE CLAMPS ARE NOT MOVED TO A NEW LOCATION AFTER EACH TREATMENT, NO OTHER PRODUCTS ARE UTILIZED WITH THE DEVICE. TREATMENT WAS COMPLETED BY REPLACING THE DEVICE WITH A NEW ONE. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, NO CLEANER WAS USED ON THE DEVICE, NO DICO ADDITIVES WERE USED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS BLOOD LOSS OF 3ML. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318584 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030209, K192302. One submission often covers many models, so check the product and lot details in each record.

• Z-0421-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
• Z-0422-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
• Z-0426-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
• Z-0423-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
• Z-0425-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
• Z-0424-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
• Z-1955-2019 · Apr 29, 2019 · Terminated
  MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 88156
• Z-0234-04 · Dec 2, 2003 · Terminated
  Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195
• Z-0233-04 · Dec 2, 2003 · Terminated
  Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192