MAHURKAR 8888135241Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 10884521006539), received between Dec 6, 2017 and Oct 15, 2025 — classified as 1 death, 8 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (48 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 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE PROCEDURE, DURING THE COMPLETION OF CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY), THE MEDICAL STAFF OBSERVED A SMALL CRACK AND RUPTURE AT THE CATHETER TIP (LUER ADAPTER), ALLOWING FLUID TO LEAK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. 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(S) 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. FORTUNATELY, AS THE TREATMENT WAS JUST CONCLUDING, NO ADVERSE OUTCOMES OCCURRED. SINCE THE PATIENT REQUIRED SUBSEQUENT HEMODIALYSIS, THE CATHETER WAS REPLACED AS A REMEDIAL ACTION, AND INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THE TREATMENT WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23281102 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WITH UREMIA UNDERWENT PLACEMENT OF A TEMPORARY INGUINAL CHRONIC CARBOTHANE CATHETER FOR HEMODIALYSIS ON (B)(6). FOLLOWING CATHETER INSERTION, REGULAR HEMODIALYSIS WAS INITIATED. ON (B)(6), THE PATIENT DEVELOPED FEVER AND CHILLS, WITH A MAXIMUM BODY TEMPERATURE OF 39.5°C. PHYSICAL EXAMINATION REVEALED COARSE BREATH SOUNDS IN BOTH LUNGS WITHOUT OBVIOUSLY OR MOIST RALES. A SMALL AMOUNT OF PURULENT FLUID WAS OBSERVED AT THE INGUINAL CATHETER SITE. AUXILIARY TESTS SHOWED ON (B)(6) AT 08:18 THAT THE WHITE BLOOD CELL COUNT WAS 13.86×10^9/L, THE NEUTROPHIL PERCENTAGE WAS 91.8%, AND THE PROCALCITONIN WAS 0.18 NG/ML, SUGGESTING A POSSIBLE CATHETER-RELATED INFECTION. THE CATHETER WAS REMOVED, AND PURULENT FLUID WAS SENT FOR BLOOD CULTURE, WHICH GREW STAPHYLOCOCCUS AUREUS. 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 USED ON THE DEVICE. 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. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIB

  Patient problems: Bacterial Infection; Chills; Fever; High White Blood Cell Count

  MAUDE report 22945470 ↗
• MalfunctionJun 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, ON THE EVENT DAY, DURING THE DIALYSIS SESSION, THE PHYSICIAN OBSERVED INADEQUATE BLOOD FLOW FROM THE CATHETER, RESULTING IN INSUFFICIENT DIALYSIS, AND TEGO WAS NOT UTILIZED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED BY CONTINUOUS REPOSITIONING OF THE CATHETER, WHICH WAS TIME-CONSUMING AND INCREASED THE WORKLOAD OF THE MEDICAL STAFF, LEADING TO PATIENT DISCOMFORT AND ANXIETY. A REPAIR KIT WAS NOT USED. THERE WAS NO BLOOD TRANSFUSION REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181526 ↗
• InjuryJun 3, 2025Difficult to Remove; Premature Indicator Activation; Difficult to Remove; Premature Indicator Activation

  ACCORDING TO THE REPORTER, THE PATIENT NEEDED TO REPLACE THE FEMORAL VEIN HEMODIALYSIS CATHETER. REPEATEDLY PUNCTURING THE GUIDEWIRE FAILED TO ENTER THE TARGET BLOOD VESSEL THROUGH THE PUNCTURE NEEDLE. AT THE SAME TIME, WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE FOR RE-PUNCTURE, IT WAS FOUND THAT THE GUIDEWIRE COULD NOT BE REMOVED. AFTER SEVERAL ATTEMPTS, THE GUIDEWIRE WAS REMOVED. THERE WAS NO OBVIOUS BENDING OF THE GUIDEWIRE, BUT IT WAS FOUND THAT THE MATCHING DEGREE BETWEEN THE GUIDEWIRE AND THE PUNCTURE NEEDLE WAS NOT HIGH. THE GUIDE WIRE WAS STUCK WHEN PASSING THROUGH THE NEEDLE TIP, WHICH SERIOUSLY AFFECTED THE PUNCTURE EFFECT AND CAUSED LOCAL DAMAGE TO THE PATIENT'S BLOOD VESSEL.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 22136812 ↗
• MalfunctionJun 3, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE SURGICAL PUNCTURE, THE GUIDEWIRE WAS DEFORMED, AND THE TIP WAS FOUND TO BE ROUGH DURING THE DILATION PERIOD. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136054 ↗
• MalfunctionMay 21, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PUNCTURE, THE GUIDEWIRE GOT STUCK IN THE NEEDLE AND CANNOT BE MOVED. THERE ARE THREE CONSECUTIVE CATHETER CHANGES. THE SAME ISSUE WAS OBSERVED DURING ALL THREE CONSECUTIVE CATHETER CHANGES. ALL THREE CATHETER CHANGES OCCURRED DURING THE SAME EVENT. ALL THREE CATHETERS WERE REPORTED TO HAVE BEEN IN THE SAME PATIENT. THERE WAS NOTHING UNUSUAL TO OBSERVE ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. FLUSHING WAS DONE, AND THE RESULT WAS NORMAL. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO 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. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE GUIDEWIRE PROVIDED WITH THE KIT WAS BEING USED. THE GUIDEWIRE WAS INTACT UPON REMOVAL. THE GUIDEWIRE WAS STUCK IN THE NEEDLE AND WAS REMOVED FROM THE PATIENT TOGETHER WITH THE NEEDLE. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH THE NEW CATHETER, AND THE SURGERY WAS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066553 ↗
• MalfunctionMay 21, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PUNCTURE, THE GUIDEWIRE GOT STUCK IN THE NEEDLE AND CANNOT BE MOVED. THERE ARE THREE CONSECUTIVE CATHETER CHANGES. THE SAME ISSUE WAS OBSERVED DURING ALL THREE CONSECUTIVE CATHETER CHANGES. ALL THREE CATHETER CHANGES OCCURRED DURING THE SAME EVENT. ALL THREE CATHETERS WERE REPORTED TO HAVE BEEN IN THE SAME PATIENT. THERE WAS NOTHING UNUSUAL TO OBSERVE ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. FLUSHING WAS DONE, AND THE RESULT WAS NORMAL. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO 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. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE GUIDEWIRE PROVIDED WITH THE KIT WAS BEING USED. THE GUIDEWIRE WAS INTACT UPON REMOVAL. THE GUIDEWIRE WAS STUCK IN THE NEEDLE AND WAS REMOVED FROM THE PATIENT TOGETHER WITH THE NEEDLE. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH THE NEW CATHETER, AND THE SURGERY WAS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066543 ↗
• MalfunctionMay 21, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PUNCTURE, THE GUIDEWIRE GOT STUCK IN THE NEEDLE AND CANNOT BE MOVED. THERE ARE THREE CONSECUTIVE CATHETER CHANGES. THE SAME ISSUE WAS OBSERVED DURING ALL THREE CONSECUTIVE CATHETER CHANGES. ALL THREE CATHETER CHANGES OCCURRED DURING THE SAME EVENT. ALL THREE CATHETERS WERE REPORTED TO HAVE BEEN IN THE SAME PATIENT. THERE WAS NOTHING UNUSUAL TO OBSERVE ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. FLUSHING WAS DONE, AND THE RESULT WAS NORMAL. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO 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. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE GUIDEWIRE PROVIDED WITH THE KIT WAS BEING USED. THE GUIDEWIRE WAS INTACT UPON REMOVAL. THE GUIDEWIRE WAS STUCK IN THE NEEDLE AND WAS REMOVED FROM THE PATIENT TOGETHER WITH THE NEEDLE. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH THE NEW CATHETER, AND THE SURGERY WAS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066481 ↗
• MalfunctionMay 6, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING CATHETER INSERTION, THE GUIDEWIRE WAS STUCK THROUGH THE PUNCTURE NEEDLE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971786 ↗
• MalfunctionApr 10, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE GUIDEWIRE WAS TWISTED AND BIFURCATED AND CANNOT BE DELIVERED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE; THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGE ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS NOT PERFORMED PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT HANDLED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO OTHER PRODUCT USED ON THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE GUIDEWIRE WAS NOT FULLY INSERTED AND WAS INTACT WHEN REMOVED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE INCIDENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPLACED. THE PROCEDURE CONTINUED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21814903 ↗
• MalfunctionMar 27, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE GUIDE WIRE WAS DEFORMED AND ABNORMAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708166 ↗
• MalfunctionMar 14, 2025Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A RUPTURE IN THE CATHETER EXTENSION TUBE, AND OOZING BLOOD WAS FOUND. IT WAS ALSO STATED THAT THERE WAS A LEAK AT THE BIFURCATE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS OR DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS DONE WITH NO ABNORMALITIES. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE, AND TEGO WAS NOT UTILIZED. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. AN EXTRACORPOREAL CIRCULATION LINE WAS THE OTHER PRODUCT UTILIZED WITH THE DEVICE. THE CATHETER WAS REPLACED AS A REMEDIAL ACTION. A SMALL AMOUNT OF BLOOD LOSS OCCURRED, AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. NO 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 21606406 ↗
• MalfunctionMar 12, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING CATHETER IMPLANTATION, A CRACK AND LEAK WERE FOUND AT THE JUNCTION OF THE SILICONE TRANSPARENT TUBE NEAR THE ARTERIAL END ADAPTER. THERE WAS NO ISSUE WITH THE LUER ADAPTER, AND TEGO WAS NOT UTILIZED. THE CLEANING AGENT USED ON THE DEVICE WAS NORMAL SALINE, AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE USE. FLUSHING WAS PERFORMED, AND NO ABNORMALITIES WERE FOUND. NO OTHER DAMAGE WAS OBSERVED ON THE PRODUCT WHERE THE LEAK OCCURRED. A BLOOD CIRCUIT TUBE WAS USED WITH THE DEVICE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE, ONLY NORMAL USE. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION, THE CATHETER WAS EXPLANTED AND REPLACED WITH A NEW ONE OF THE SAME PRODUCT ID (IDENTIFIER) ON THE SAME DAY AS THE EVENT, AND THE PROCEDURE WAS COMPLETED. THERE WAS A 2 ML BLOOD LOSS, BUT NO BLOOD TRANSFUSION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583296 ↗
• InjuryMar 10, 2025Adverse 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 ON (B)(6) 2024, FOR A PHYSICAL EXAMINATION, AND THE TEMPERATURE (T) WAS 36.4 DEGREES CELSIUS, PULSE (P) WAS 86 TIMES PER MINUTE, RESPIRATORY RATE (R) WAS 20 TIMES PER MINUTE, AND BLOOD PRESSURE (BP) WAS 148/64 MILLIMETERS OF MERCURY. UNDER AUXILIARY EXAMINATION, IN THE BLOOD ROUTINE (BLOOD TEST), WHITE BLOOD CELL COUNT WAS 6.71 × 10^9 PER LITER, AND THE NEUTROPHIL PERCENTAGE WAS 65.5%. DUE TO UREMIA, HEMODIALYSIS WAS PERFORMED AT 11:00 ON (B)(6). THE WEIGHT BEFORE DIALYSIS WAS 44.3 KILOGRAMS. A BLOOD ACCESS WAS ESTABLISHED THROUGH THE RIGHT INGUINAL VEIN CATHETERIZATION; AFTER HEMODIALYSIS TREATMENT, THE PATIENT RETURNED TO THE WARD SAFELY. THE DRESSING AT THE RIGHT INGUINAL CATHETERIZATION SITE WAS DRY, THERE WAS NO BLOOD OOZING, THERE WERE NO COMPLAINTS OF DISCOMFORT, AND THE BODY TEMPERATURE WAS 36.4 DEGREES CELSIUS. HEMODIALYSIS WAS PERFORMED REGULARLY ON THE 25TH AND 26TH. ON (B)(6) 2024, AT 21:05, THE PATIENT DEVELOPED A HIGH FEVER WITH A BODY TEMPERATURE OF 38.8 DEGREES CELSIUS. THE WHITE BLOOD CELL COUNT WAS 13.52*10^9 PER LITER ELEVATED, THE NEUTROPHIL PERCENTAGE WAS 87.6% INCREASED, THE HEMOGLOBIN WAS 44

  Patient problems: Fever; Unspecified Infection

  MAUDE report 21567563 ↗
• MalfunctionMar 10, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, IT WAS FOUND THAT THE GUIDEWIRE WAS LOOSE OR SPREAD OUT AND COULD NOT BE REMOVED FROM THE NEEDLE HOLE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. ALCOHOL WAS THE CLEANING AGENT THAT WAS USED ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE GUIDEWIRE PROVIDED WITH THE KIT WAS THE ONE BEING USED. A POST-PROCEDURE X-RAY WAS NOT DONE. THERE WAS APPROXIMATELY 5 ML OF BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. AS A REMEDIAL ACTION, THE GUIDEWIRE WAS REMOVED AND REPLACED TOGETHER WITH THE NEEDLE. WHEN REMOVED, THE GUIDEWIRE WAS STILL INTACT BUT SPREAD OUT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21567021 ↗
• MalfunctionMar 6, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER AFTER THE PUNCTURE WAS SUCCESSFUL, A CRACK AND BLOOD LEAKAGE WERE FOUND BETWEEN THE EXTENSION TUBE AND THE BLUE SIDE LUER CONNECTOR, WITH A RUPTURE DETECTED DURING THE OPERATION. THERE WERE NO OTHER DAMAGES FOUND ON THE PRODUCT WHERE THE LEAKAGE WAS FOUND. THERE WAS NO ISSUE WITH THE LUER ADAPTER, AND TEGO WAS NOT UTILIZED. NO CLEANING AGENT WAS USED ON THE DEVICE, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT PERFORMED BEFORE USE, AND NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS APPLIED, AND THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION, THE CATHETER WAS REPLACED WITH ANOTHER FROM THE SAME LOT AND ID AND WAS RE-IMPLANTED ON THE SAME DAY AS THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THE EVENT, AND THERE WAS NO BLOOD LOSS OR NEED FOR A BLOOD TRANSFUSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21533923 ↗
• MalfunctionMar 3, 2025Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE PATIENT WAS IN LONG-TERM HEMODIALYSIS. THREE DAYS BEFORE THE EVENT, THE PATIENT WAS ADMITTED TO THE ICU (INTENSIVE CARE UNIT) DUE TO THE SEPSIS. ON THE MORNING OF THE EVENT, THE NURSE ON DUTY DISCOVERED THAT THE PATIENT'S ORIGINAL HEMODIALYSIS FISTULA WAS OCCLUDED, AND HEMODIALYSIS TREATMENT COULD NOT BE PERFORMED. THE DOCTOR ORDERED THE PATIENT TO HAVE A CENTRAL VENOUS ACCESS FOR LOWER EXTREMITY HEMODIALYSIS. ON THE EVENING OF THE EVENT, THE NURSE ON DUTY USED A CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS TO ESTABLISH THE ACCESS FOR THE PATIENT. AFTER THE PUNCTURE WAS SUCCESSFUL, IT WAS FOUND THAT THE CATHETER WAS LEAKING BLOOD. THE NURSE ON DUTY IMMEDIATELY REPLACED IT WITH A NEW CATHETER, AND THEN THE ACCESS WAS SUCCESSFULLY ESTABLISHED. THE NURSE ON DUTY SEALED THE LEAKING CATHETER AND REPORTED IT TO THE EQUIPMENT DEPARTMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21507548 ↗
• MalfunctionJan 3, 2025Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS UNDERGOING BEDSIDE DIALYSIS IN THE ICU. THE DOCTOR CONNECTED THE HEMODIALYSIS CATHETER NORMALLY. HALF AN HOUR LATER, THE NURSE DISCOVERED THAT THE HEMODIALYSIS CATHETER HAD SLIPPED OFF. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE AND WITH NORMAL RESULTS. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. 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. THE STITCHES HOLD, THE RING OF THE SUTURE WING WAS BROKEN, AND THE SEPARATION FROM THE RETAINING RING (WING) FAILED. AS A REMEDIAL ACTION DONE, THE DOCTOR WAS CONTACTED PROMPTLY TO REMOVE IT AND REPLACE THE HEMODIALYSIS CATHETER. THIS WAS ALSO THE INTERVENTION/TREATMENT PERFORMED. THE CATHETER HAS BEEN IN PLACE FOR 1 HOUR. REINTUBATION WAS THE MEDICAL INTERVENTION. THE TREATMENT CONTINUED AFTER THE CATHETER WAS REPLACED. THERE WAS 2 ML OF BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065007 ↗
• MalfunctionJan 2, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE VENOUS END OF THE CATHETER HOSE WAS FOUND TO BE BROKEN. IT WAS STATED THAT THERE WAS A HOLE IN THE INTRAVENOUS HOSE, AND THERE WAS NO PROBLEM WITH THE LUER CONNECTOR. THERE WAS NO LEAK, AND THE CATHETER WAS NOT REPAIRED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. TEGO AND CLEANING AGENT WERE NOT USED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS NOT PERFORMED, AND THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE METHOD BEING UTILIZED TO TIGHTEN THE ADAPTERS WAS BY HAND. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS COMPLETELY REMOVED AND REPLACED ON THE SAME DAY OF THE EVENT WITH ANOTHER PRODUCT THAT HAS THE SAME PRODUCT ID AND LOT NUMBER. THE PROCEDURE WAS COMPLETED, AND THERE WAS NO REQUIRED INTERVENTION DUE TO THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TR ANSFUSION WAS NOT PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053414 ↗
• MalfunctionDec 5, 2024Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE PATIENT HAD SEPTIC SHOCK AND UNDERWENT LEFT FEMORAL VEIN SHEATH CATHETERIZATION AND CVVHDF (CONTINUOUS VENO-VENOUS HEMODIAFILTRATION) BLOOD FILTRATION TREATMENT. AFTER BEING PUT ON THE MACHINE, IT WAS FOUND THAT THERE WAS A SMALL LEAKAGE OF BLOOD OUTSIDE THE SHEATH. THE CATHETER ACCESSORIES WERE REPLACED IMMEDIATELY, AND THE PATIENT WAS PUT ON THE MACHINE SMOOTHLY. THE ORIGINAL PIPELINE OF THE BLOOD LEAKAGE WAS CONTACTED BY THE MANUFACTURER FOR ANALYSIS AND TREATMENT. THERE WAS NO SITUATION OF COMBINED MEDICATION/DEVICES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855655 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD CHRONIC KIDNEY DISEASE STAGE 5. ON (B)(6) THE PATIENT UNDERWENT RIGHT INGUINAL CATHETERIZATION UNDER LOCAL ANESTHESIA, AND THE OPERATION WENT SMOOTHLY. ON OCTOBER 17, OCTOBER 18, AND OCTOBER 19, HEMODIALYSIS WAS PERFORMED RESPECTIVELY, AND THE BLOOD SUGAR PROCESS WENT SMOOTHLY. ON (B)(6), THE PATIENT DEVELOPED FEVER, WITH A BODY TEMPERATURE OF 38.8, ACCOMPANIED BY CHILLS, PAIN AT THE RIGHT INGUINAL CATHETERIZATION SITE, NO COUGH, SPUTUM, FREQUENT URINATION, URGENCY, OR PAIN. PE (PHYSICAL EXAMINATION) OBSERVATIONS, A SMALL AMOUNT OF PURULENT SECRETIONS WERE SEEN AT THE RIGHT INGUINAL CATHETERIZATION SITE, AND THE REST OF THE PHYSICAL EXAMINATION HAD NOTHING SPECIAL. CONSIDERING CATHETER INFECTION, AN ORAL MEDICATION AMPICILLIN SODIUM AND SULBACTAM SODIUM WAS ADDED FOR ANTI-INFECTION. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE WITH NO ABNORMALITY. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WERE NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH IODINE WIPED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER DEF ECTS/DAMAGES FOUND ON

  Patient problems: Chills; Fever; Pain; Unspecified Infection

  MAUDE report 20786486 ↗
• MalfunctionNov 13, 2024Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE DOCTOR PERFORMED BEDSIDE DIALYSIS ON THE PATIENT AND CORRECTLY CONNECTED THE CENTRAL VENOUS CATHETER FOR HEMODIALYSIS. DURING THE DIALYSIS PROCESS, THE DOCTOR ON DUTY FOUND THAT THE FIXING BUCKLE OF THE PATIENT¿S FEMORAL VEIN CATHETER HAD SLIPPED OFF, SO HE IMMEDIATELY STOPPED THE DIALYSIS. 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 NORMAL SALINE. THERE WAS NO LEAK, AND THE TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. 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 REPORTED PRODUCT WAS REPLACED WITH A NEW HEMODIALYSIS CATHETER FOR THE PATIENT. AFTER REPLACEMENT, THE PROCEDURE WAS COMPLETED. BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT WAS STABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20671425 ↗
• MalfunctionNov 12, 2024Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS TRANSFERRED FROM THE RESPIRATORY DEPARTMENT DUE TO END-STAGE RENAL DISEASE, AND THE DOCTOR INSERTED A RIGHT FEMORAL VEIN HEMODIALYSIS CATHETER. AFTER THE CATHETER WAS PLACED, THE PATIENT WENT TO THE HEMODIALYSIS ROOM FOR HEMODIALYSIS TREATMENT AND RETURNED TO THE WARD AFTER THE DIALYSIS WAS COMPLETED. THE NEXT DAY, THE ACCOMPANYING STAFF REPORTED TO THE NURSE STATION THAT THE TEMPORARY HEMODIALYSIS TUBE FROM THE RIGHT FEMORAL VEIN WAS REMOVED BY THE PATIENT. THEY IMMEDIATELY WENT TO THE BEDSIDE TO CHECK ON THE PATIENT. THE PATIENT'S HANDS WERE RESTRAINED WITH WRISTBANDS, AND THE TEMPORARY HEMODIALYSIS TUBE FROM THE RIGHT FEMORAL VEIN HAD COMPLETELY COME OUT FROM THE SECUREMENT WING, BUT THE CATHETER WAS INTACT. THE CATHETER FIXING BUTTERFLY WINGS AND SUTURES WERE STILL INTACT AND FIXED TO THE LEG SKIN. THE AREA AROUND THE PUNCTURE SITE WAS BRUISED PURPLE WITH NO ACTIVE BLEEDING. WHEN QUESTIONING THE PATIENT, THE PATIENT DID NOT KNOW THAT THE HEMODIALYSIS TUBE HAD BEEN REMOVED. FLUSHING WAS PERFORMED BEFORE USE, AND THERE WAS NO ABNORMALITY. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES ON THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665974 ↗
• MalfunctionNov 12, 2024Break; Break

  ACCORDING TO THE REPORTER, AFTER THE TEMPORARY TUBE WAS IMPLANTED, TRACHOMA WAS FOUND IN THE TUBE BODY WHICH MEANS MINOR HOLES THAT WERE DETECTABLE TO THE NAKED EYE, AND A SMALL AMOUNT OF CONTINUOUS BLOOD WAS CONTINUOUSLY LEAKING OUT. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK ON THE CATHETER SHAFT BUT NOT IN THE JUNCTION OF THE BIFURCATE AND CATHETER. THERE WAS NO LUER ADAPTER ISSUE. OTHER DEFECTS/DAMAGES ON THE PRODUCT IN ADDITION TO THE REPORTED ISSUE. THE REMEDIAL ACTION TAKEN WAS NEW CATHETER REPLACEMENT AND THE TREATMENT WAS CONTINUED AND COMPLETED. THERE WAS 30 ML BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663370 ↗
• MalfunctionSep 30, 2024Product Quality Problem; Obstruction of Flow; Detachment of Device or Device Component; Product Quality Problem; Obstruction of Flow; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE REPORTED PRODUCT HAD LOW USEFUL LIFE AND HAD A GREATER THAN NORMAL NEED FOR EXCHANGES. IT WAS STATED THAT IT WAS VIA ARTERIAL ROUTE ONLY, WITH 2 WIDE ORIFICES THAT WERE THEN BLOCKED. IT WAS DIFFICULT TO MANAGE THE GUIDE WIRE, AS IT DID NOT HAVE STABILITY FOR CONNECTION WITH THE SYRINGE, MAKING THE PASSAGE TO THE VEIN DIFFICULT, AND SOMETIMES NEEDED A NEW VEIN PUNCTURE DUE TO THE DIFFICULTY TO RUN THE GUIDE WIRE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20340560 ↗

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-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-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-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-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-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-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-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