MAHURKAR 8888135191Recalls & reported problems

Summary

The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 10884521006447), received between Oct 11, 2017 and Jul 21, 2025 — classified as 5 injuries, 170 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (97 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 175 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PHYSICIAN PERFORMED A HEMODIALYSIS CATHETER PLACEMENT. DURING THE PROCEDURE, CONTINUOUS BLOOD LEAKAGE WAS OBSERVED FROM THE CATHETER SHAFT DUE TO SMALL PERFORATIONS. THE CATHETER WAS NOT REPAIRED. A TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO OTHER PRODUCTS WERE 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 CATHETER WAS IMMEDIATELY REMOVED, AND A NEW PRODUCT WAS PREPARED AND REINSERTED AS AN INTERVENTION, AND THE PROCEDURE WAS COMPLETED. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560615 ↗
• MalfunctionJul 1, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ON MAY 26TH, A PUNCTURE WAS PERFORMED, AND ON THE DAY OF THE EVENT, A CRACK WAS OBSERVED IN THE BLOOD DIALYSIS CATHETER DURING TREATMENT. THAT EVENING AT 7:10 PM, ALL TUBING WAS INSPECTED; NO BLEEDING WAS DETECTED. DURING THE NIGHT SHIFT HANDOVER, A FURTHER EXAMINATION REVEALED BLOOD LEAKAGE ALONG THE CATHETER WALL, AND THE MACHINE WAS SET TO AUTO-CIRCULATION. FURTHER MANAGEMENT WILL BE DETERMINED AFTER PHYSICIAN ASSESSMENT. THE EQUIPMENT WAS CLEANED WITH STANDARD DISINFECTANTS, AND THE LUER ADAPTER WAS CONFIRMED TO BE NORMAL, AND THERE WAS NO ISSUE, RULING OUT EXTERNAL FORCES SUCH AS COMPRESSION. A PERFORATION WAS IDENTIFIED IN THE TRANSPARENT SEGMENT OF THE EXTENSION TUBE, RESULTING IN BLOOD LEAKAGE. AND DIALYSIS WAS CONTINUED. THE AFFECTED PRODUCT WAS REPLACED AS REMEDIAL ACTION AND INTERVENTION. 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. BESIDES THE REPORTED ISSUE, THERE WERE NO VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT T

  Patient problems: Insufficient Information

  MAUDE report 22378639 ↗
• MalfunctionJun 12, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, NORMAL DIALYSIS WAS PERFORMED AFTER INTUBATION ON (B)(6) 2025, AND THE PROBLEM WAS FOUND ON (B)(6) 2025, THAT THERE WAS A HOLE IN THE OUTER TUBE¿S TRANSPARENT BODY PART. THERE WAS A PARTIAL LIQUID LEAK (BLOOD LEAKAGE) AT THE JUNCTION OF THE EXTENSION TUBE AND THE LUER ADAPTER (BLUE VENOUS). REGULAR CLEANING AGENTS WERE USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE WHOLE CATHETER WAS REPLACED AS A REMEDIAL ACTION TO ADDRESS THE ISSUE. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED, AND NO MEDICAL INTERVENTION OR TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194515 ↗
• MalfunctionJun 10, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT WAS FOUND TO HAVE BLOOD OOZING AT THE BLUE LUER AND CATHETER CONNECTION WHEN THE TEMPORARY CATHETER WAS PLACED AND WAS IMMEDIATELY REPLACED WITH A NEW CATHETER AS A REMEDIAL ACTION, AND THE PATIENT HAD 2 SURGICAL INJURIES. THE PROCEDURE WAS ABLE TO PROCEED AND COMPLETE AFTER THE REMEDIAL ACTION. THE CATHETER WAS NOT REPAIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS 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. NO EXCESSIVE FORCE USED ON THE DEVICE. HAND WAS THE METHOD UTILIZED TO TIGHTEN THE ADAPTERS. NO INTERVENTION/TREATMENT WAS 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 22180041 ↗
• MalfunctionApr 21, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS CENTRAL VENOUS CATHETER PLACEMENT, IT WAS FOUND THAT THE GUIDEWIRE SPRING WAS LOOSE, AND THE HEMODIALYSIS CENTRAL VENOUS CATHETER WAS UNABLE TO IMPLANT. THE GUIDEWIRE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873246 ↗
• MalfunctionMar 17, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THREE DAYS AFTER THE CATHETER WAS IMPLANTED, DURING HEMODIALYSIS, IT WAS FOUND THAT THE CONNECTION BETWEEN THE BLUE LUER ADAPTER AND THE HOSE WAS BROKEN DUE TO A CRACK. THE LEAK OCCURRED AT THE EXIT SITE (OUTLET POSITION). THERE WAS NO ISSUE WITH THE LUER CONNECTOR, AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. TEGO WAS NOT USED. ALCOHOL WAS USED AS THE CLEANING AGENT ON THE DEVICE. FLUSHING WAS PERFORMED, AND NO LEAKS WERE FOUND AT THE TIME. NO EXCESSIVE FORCE WAS USED. THE CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION, THE CATHETER WAS REMOVED AND REPLACED, AND THE TREATMENT WAS COMPLETED. THERE WAS A 5 MILLILITERS BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS PERFORMED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618864 ↗
• MalfunctionMar 14, 2025Break; Break

  ACCORDING TO THE REPORTER, TWO (2) DAYS AFTER THE CATHETER HAD BEEN IN PLACE, DURING VISUAL INSPECTION BEFORE TREATMENT, IT WAS OBSERVED THAT THERE WAS A CRACK (RUPTURED) AND A LEAK AT THE VENOUS (BLUE) LUER ADAPTER (END INTERFACE). ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE, AND THE DEVICE WAS TIGHTENED BY HAND. IODINE WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. EXCESSIVE FORCE WAS NOT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE CATHETER WAS NOT REPAIRED. THE REPORTED PRODUCT WAS REMOVED AS A REMEDIAL ACTION. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO MEDICAL INTERVENTION/TREATMENT DONE TO THE PATIENT AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607425 ↗
• MalfunctionMar 3, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE GUIDEWIRE WAS TOO SOFT, PREVENTING SUCCESSFUL CATHETER PLACEMENT. THE GUIDEWIRE DEVELOPED AN UNINTENDED LARGE LOOP NEAR THE TIP (COILED). AS A RESULT, THE CATHETER COULD NOT BE PLACED, AND NO CATHETER REPAIRS WERE MADE. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE CLEANING WAS PERFORMED USING THE CLEANING AGENT RECOMMENDED BY THE MANUFACTURER. NO EXCESSIVE FORCE WAS APPLIED TO THE PRODUCT. THE GUIDE WIRE DID NOT BREAK INTO PIECES. THE GUIDE WIRE AND NEEDLE USED WERE THE ONES INCLUDED IN THE KIT. THERE WAS NO VISUAL DAMAGE NOTED ON THE NEEDLE ITSELF. THE DIMENSION(S) OF THE GUIDE WIRE AND NEEDLE MATCHED WHAT WAS INDICATED ON THE LABEL. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. THE PRODUCT WAS NOT REPLACED. THE PROCEDURE WAS COMPLETED. THERE WAS NO 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 21509239 ↗
• MalfunctionJan 31, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE CATHETER HAD A LEAK AND A CUT AT THE JUNCTION OF EXTENSION TUBE AND BIFURCATE. IT WAS ALSO STATED THAT DURING THE OPERATION, IT WAS OBSERVED THAT THE EXTERNAL EXTENSION TUBE AT THE VENOUS LUER ADAPTER WAS RUPTURED. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE WITH NO ABNORMALITIES FOUND. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THE CATHETER WAS REPLACED AS A REMEDIAL ACTION AND INTERVENTION/TREATMENT 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 21283627 ↗
• MalfunctionJan 23, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ONE MONTH AFTER INSERTION, DURING NORMAL USE, THERE WAS A BLOOD LEAK AT THE JUNCTION OF THE VENOUS SILICONE EXTENSION TUBE NEAR THE BIFURCATE OF THE CATHETER. THE CATHETER WAS NOT REPAIRED. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT USED. THERE WAS NO LUER ADAPTER ISSUE. NO OTHER PRODUCTS USED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIORTO USE. NO OTHER DEFECTS/DAMAGES ON THE PRODUCT. FLUSHING WAS PERFORMED PRIOR TO USE AND HAD NO LEAKS. THE CLAMP WAS NOT MOVED PERIODICALLY. THE PRODUCT WAS NOT REPLACED. CATHETER REMOVAL WAS THE REMEDIAL ACTION PERFORMED TO ADDRESS THE ISSUE. THERE WAS 10 MILLILITERS OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217415 ↗
• MalfunctionJan 22, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE, WHEN THE PATIENT WAS ABOUT TO RECEIVE TREATMENT, IT WAS FOUND THAT THE ARTERIAL JOINT WAS BROKEN (CRACK LUER ADAPTER), AND A PIECE OF THE ARTERIAL END FELL OFF, FORMING A GAP. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE AND FOUND THE CONNECTOR WAS DAMAGED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO EXCESSIVE FORCE 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 INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH THE SAME ID ON THE SAME DAY WHEN THE EVENT OCCURRED. THE TREATMENT PROCEEDED AND COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210180 ↗
• MalfunctionJan 10, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO RENAL INSUFFICIENCY AND HAD A CATHETER IMPLANTED FOR DIALYSIS TREATMENT. DURING THE TREATMENT, IT WAS FOUND THAT THE CATHETER'S JUNCTION BETWEEN THE BLUE VENOUS EXTENSION TUBE AND BIFURCATE/HUB WAS LEAKING BLOOD WHERE A CRACK WAS NOTED. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CATHETER WAS NOT REPAIRED. NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS REMOVED IMMEDIATELY AS REMEDIAL ACTION TO ADDRESS THE ISSUE. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125102 ↗
• MalfunctionJan 10, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING TREATMENT, OOZING BLOOD WAS FOUND. CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AT THE JUNCTION OF THE EXTENSION TUBE (VENOUS END) AND BIFURCATE. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CLAMP WAS MOVED PERIODICALLY. THE REMEDIAL ACTION PERFORMED TO ADDRESS THE ISSUE WAS TO REPLACE THE CATHETER. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124874 ↗
• MalfunctionJan 8, 2025Break; Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103140 ↗
• MalfunctionJan 3, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED TO THE ICU (INTENSIVE CARE UNIT) ON (B)(6) AND UNDERWENT HEMOFILTRATION USING A CATHETER KIT. ON (B)(6), DURING THE EXAMINATION BEFORE HEMOFILTRATION, THE DOCTOR FOUND A 0.2-0.3 MM (MILLIMETER) CRACK ON THE BROWN CATHETER TIP, AND IT COULD NOT BE USED. THE PATIENT NEEDED A SECOND INTUBATION; THE CATHETER WAS REPLACED WITH A NEW CATHETER KIT, AND THE MATERIAL LIBRARY WAS NOTIFIED AS A PRELIMINARY ACTION, WHICH CAUSED THE PATIENT TO SUFFER AN ADDITIONAL INTUBATION INJURY (THE ORIGINAL DAMAGED CATHETER WAS NEEDED TO BE REMOVED, AND A NEW CATHETER WAS NEEDED TO BE IMPLANTED) AND PROLONGED THE DAY'S HEMOFILTRATION TREATMENT TIME. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE ADAPTER WAS TIGHTENED BY HAND. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. EXTUBATION WAS NEEDED AS THE MEDICAL INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE EVENT DID NOT LEAD TO BLOOD VESSEL DAMAGE TO THE PATIENT. THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND BLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065042 ↗
• MalfunctionJan 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING CATHETER WEAR, THE VENOUS END WAS FOUND TO BE CRACKED, AND THE CATHETER WAS EXTUBATED AND REPOSITIONED. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AT THE BLUE LUER ADAPTER. THERE WAS A CRACK IN THE BLUE (VENOUS) LUER ADAPTER. THERE WAS NO ABNORMALITY OBSERVED BEFORE USE. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED WITH PRIOR PRODUCT PLACEMENT. THERE WAS AN UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. REPLACEMENT OF THE CATHETER WAS THE REMEDIAL ACTION PERFORMED AND ALSO THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND 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 21053441 ↗
• MalfunctionOct 23, 2024Break; Break

  ACCORDING TO THE REPORTER, THERE WAS A CRACK IN THE ARTERIAL SEGMENT PORT (RED LUER ADAPTER). THE CATHETER WAS REPAIRED. THERE WAS LEAK AT THE LUER ADAPTER. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. IODINE DISINFECTION WAS THE CLEANING AGENT USED THE DEVICE. TEGO WAS UTILIZED. THE INSERTION SITE WAS NOT TREATED WITH PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515911 ↗
• MalfunctionSep 16, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE DESIGNATED DEPARTMENT OF THE FACILITY REPORTED THAT DURING THE FEMORAL VEIN PUNCTURE FOR THE PATIENT, THE CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS WAS USED BY THE DOCTOR. IT WAS STATED THAT THE GUIDEWIRE IN THE CENTRAL VENOUS CATHETER BROKE, WHICH RESULTED IN PUNCTURE FAILURE. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. 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. FLUSHING WAS NOT DONE PRIOR TO USE. TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE GUIDEWIRE WAS REMOVED BY HAND. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. THE GUIDEWIRE WAS STILL INTACT WHEN REMOVED, AND ALL THE PIECES WERE ACCOUNTED FOR. AS A REMEDIAL ACTION, THE REPORTED PRODUCT, INCLUDING THE GUIDEWIRE, WAS REPLACED. THE PROCEDURE WAS THEN CONTINUED, RE-PUNCTURE WAS DONE, AND THE CATHETER WAS PL

  Patient problems: Insufficient Information

  MAUDE report 20224097 ↗
• MalfunctionAug 12, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging

  ACCORDING TO THE REPORTER, DURING THE INSTALLATION OF THE RIGHT DOUBLE LUMEN CATHETER, WHEN THE DOCTOR WAS PERFORMING THE PROCEDURE AND CHANNELING THE DEVICE, THE DOCTOR TRIED TO REMOVE THE GUIDE AND THE CATHETER ONE TIME, FELT DIFFICULTY, TRACED, AND REMOVED THE GUIDE COMPLETELY. IT WAS OBSERVED TO BE STRETCHED, LOSING ITS SHAPE (FRAYED), SO THEY PERFORMED THE PROCEDURE AGAIN. WITH A NEW DEVICE WITH THE SAME LOT, THIS TIME IN THE LEFT JUGULAR AREA. THE GUIDE WIRE WAS INSERTED AT 10 CM, AND A STOP WAS FELT, WHEN PERFORMING THE REMOVAL MANEUVER OF THE NEW GUIDE, IT WAS OBSERVED THAT IT WAS FRAYED LIKE THE PREVIOUS ATTEMPT. AN EXCESSIVE FORCE WAS USED TO REMOVE THE GUIDE WIRE. ALL PIECES WERE ACCOUNTED FOR. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. CLOREXHIDINA 2% WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO DAMAGE/DEFECT TO THE CATHETER ITSELF. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. TEGO WAS NOT UTILIZED. THE SHEATH/CATHETER THAT CAME WITH THE KIT WAS THE ONE USED. THERE WAS NO OCCLUSION. FLUSHING WAS DONE PRIO

  Patient problems: Insufficient Information

  MAUDE report 19968284 ↗
• MalfunctionAug 11, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE INSTALLATION OF THE RIGHT DOUBLE LUMEN CATHETER, WHEN THE DOCTOR WAS PERFORMING THE PROCEDURE AND CANNELING THE DEVICE, THE DOCTOR TRIED TO REMOVE THE GUIDE, FELT DIFFICULTY, TRACLED, AND REMOVED THE GUIDE COMPLETELY. IT WAS OBSERVED TO BE STRETCHED, LOSING ITS SHAPE, SO THEY PERFORMED THE PROCEDURE AGAIN. WITH A NEW DEVICE WITH THE SAME LOT, THIS TIME IN THE LEFT JUGULAR AREA. WHEN PERFORMING THE REMOVAL MANEUVER OF THE NEW GUIDE, IT WAS OBSERVED THAT IT WAS FRAYED LIKE THE PREVIOUS ATTEMPT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19957983 ↗
• MalfunctionJul 12, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT WAS POISONED BY DRUGS AND NEEDED EMERGENCY BLOOD PERFUSION. AFTER THE DOCTOR SUCCESSFULLY PLACED THE CATHETER, JUDGED WHETHER THE BLOOD FLOW WAS SUFFICIENT, THERE WAS A CRACK AT THE ARTERIAL EXTENSION TUBE ABOVE THE ADAPTER AND LEAKING BLOOD. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO CLEANING AGENT USED ON THE DEVICE. THE CLAMP WAS NOT MOVED PERIODICALLY. TEGO WAS NOT UTILIZED. FLUSHING WAS NOT DONE. IT LED TO SECONDARY INTUBATION OF THE PATIENT WHICH MEANT THE CATHETER WAS REMOVED IMMEDIATELY, REPLACED WITH A NEW ONE ON THE SAME DAY WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT, AND RE-INSERTED THE SECOND ONE TO COMPLETE THE OPERATION AS INTERVENTION AND WENT FOR BLOOD THERAPY. THERE WAS 10 MILLILITERS OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 19735791 ↗
• MalfunctionJul 11, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT WAS POISONED BY ORGANOPHOSPHORUS PESTICIDE 06 AND WAS SCHEDULED FOR HEMOPERFUSION. A TEMPORARY HEMODIALYSIS CATHETER WAS PLACED IN THE RIGHT FEMORAL VEIN AND WHEN PUT ON THE MACHINE FOR THE PATIENT, IT WAS FOUND THAT THE BLOOD WAS NOT FLOWING SMOOTHLY AT THE ARTERIAL END. AFTER CAREFULLY CHECKED THE CATHETER, IT WAS FOUND THAT AT THE CONNECTION BETWEEN THE INNER AND OUTER CATHETER OF THE ARTERIAL END CATHETER, THERE WERE LOCAL BUBBLES OVERFLOWING. THE EXACT LOCATION OF THE ISSUE WAS THE EXTENSION TUBE NEAR THE ADAPTER. IT WAS SUSPECTED THAT IT WAS CAUSED BY A SMALL LOCAL DAMAGE (CRACK) OF THE CATHETER. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO CLEANING AGENT USED ON THE DEVICE. THE CLAMP WAS NOT MOVED PERIODICALLY. TEGO WAS NOT UTILIZED. FLUSHING WAS NOT DONE. IT CAUSED THE PATIENT TO UNDERGO A SECOND CATHETER PLACEMENT. THE DOCTOR IMMEDIATELY REPLACED THE INTRAVENOUS CATHETER WITH THE SAME PRODUCT ID (IDENTIFIER) ON THE SAME DAY AND COMPLETED THE INSERTION AND THEN DRAIN THE BLOOD FOR TREATMENT. THERE WERE 10 MILLILITERS OF BLOOD LOS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724141 ↗
• MalfunctionJul 10, 2024Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS IN NORMAL CONDITION WHEN IT WAS IMPLANTED, AND IT WAS NORMAL DURING DIALYSIS ON THE SECOND DAY. HOWEVER, BEFORE THE DIALYSIS ON THE THIRD DAY, IT WAS DISCOVERED THAT THE CATHETER SUTURE WING HAD FALLEN AS A WHOLE. THE DOCTOR REPLACED THE REPORTED PRODUCT WITH A SET OF CATHETER OF THE SAME MODEL. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. REPLACED WITH A SET OF THE SAME MODEL OF CATHETER WAS THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER WAS NOT MOVED OUT OF PLACE. THE RING OF THE SUTURE WING WAS NOT BROKEN. THE STITCHES DID HOLD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711192 ↗
• MalfunctionApr 23, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, UREMIA PATIENTS NEEDED TO COMPLETE HEMODIALYSIS TREATMENT REGULARLY TO REMOVE EXCESS WATER AND TOXINS FROM THE BODY. ON (B)(6) 2024, THE PATIENT CAME TO THE HEMODIALYSIS ROOM OF OUR HOSPITAL FOR ROUTINE HEMODIALYSIS, WHICH REGULARLY REMOVED EXCESS WATER AND TOXINS FROM THE BODY. A NURSE USED A CENTRAL VENOUS CATHETER SET TO ESTABLISH VASCULAR ACCESS FOR A PATIENT TO PERFORM HEMODIALYSIS. DURING THE DIALYSIS PROCESS, THE NURSE FOUND FRESH BLOOD LEAKING FROM THE OUTER DRESSING OF THE CATHETER. AFTER MULTIPLE INSPECTIONS, IT WAS DISCOVERED THAT THE CATHETER'S SILICONE JOINT HAD A CRACK OR TEAR, AND HEMODIALYSIS COULD NOT CONTINUE. IF DIALYSIS WAS CONTINUED, AIR MIGHT ENTER THE EXTRACORPOREAL CIRCULATION LINE, CAUSING COAGULATION, AND MIGHT ENTER THE BLOOD CIRCULATION IN THE BODY, POSSIBLY CAUSING AIR EMBOLISM. THEY WERE UNABLE TO PERFORM NORMAL DIALYSIS, INCREASING THE PATIENT¿S RISK OF AIR EMBOLISM, AND INCREASING THE PATIENT¿S FINANCIAL BURDEN. THEY IMMEDIATELY REPORTED IT TO THE DOCTOR ON DUTY. THEY IMMEDIATELY DISCHARGED THE AIR IN THE PIPE, RETURNED BLOOD, AND TOOK OFF THE MACHINE. IT CAUSED THE PATIENT'S PSYCHOLOGICAL TENSION, THEY PATIENTLY EXPLAINED

  Patient problems: Insufficient Information

  MAUDE report 19166790 ↗
• MalfunctionApr 10, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE DOCTOR PERFORMED PERFUSION TREATMENT AT THE BEDSIDE. AFTER SUCCESSFULLY PLACING THE TUBE IN THE NECK, FOUND BLOOD OOZING WAS NOTED. UPON INSPECTION, THERE WAS A BREAK IN THE TUBE AT THE VENOUS END EXTENSION TUBE. THE CLAMPS MOVED TO A NEW LOCATION AFTER TREATMENT. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS DONE WITH NORMAL RESULT. THE ISSUE WAS REPORTED TO THE DOCTOR IMMEDIATELY AND REPLACED THE TUBE WITH THE SAME PRODUCT ID AND LOT AT THE SAME DAY OF THE EVENT AS REMEDIAL ACTION. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081176 ↗

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-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-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-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-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-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-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