MAHURKAR 8888135131Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884521006201), received between Jan 5, 2018 and Jun 4, 2025 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (7 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING THE PRE-OPERATIVE EXAMINATION, IT WAS FOUND THAT CATHETER ARTERY END REFLUX CLIP WAS DAMAGED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE ASIDE FROM THE ISSUE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE CLAMP ISSUE (RESULT OF THE EVENT). AS A REMEDIAL ACTION, IT WAS REPLACED WITH NEW TUBES. 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 22146959 ↗
• MalfunctionApr 30, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  THE SALES REPRESENTATIVE CONFIRMED THAT THE RETURNED SAMPLE HAD BEEN SENT BY MISTAKE, AND THERE WAS NO ISSUE TO REPORT. THERE WERE NO PROBLEMS OR COMPLAINTS ASSOCIATED WITH THE RETURNED SAMPLE, AS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940178 ↗
• MalfunctionApr 30, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  THE SALES REPRESENTATIVE CONFIRMED THAT THE RETURNED SAMPLE HAD BEEN SENT BY MISTAKE, AND THERE WAS NO ISSUE TO REPORT. THERE WERE NO PROBLEMS OR COMPLAINTS ASSOCIATED WITH THE RETURNED SAMPLE, AS REPORTED BY THE CUSTOMER. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE LUER ADAPTER WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940112 ↗
• MalfunctionFeb 6, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PLACEMENT OF A TEMPORARY INTERNAL JUGULAR VEIN CATHETER FOR RENAL DIALYSIS, THE GUIDEWIRE GOT STUCK IN THE PUNCTURE NEEDLE AND COULD NOT BE ADVANCED OR WITHDRAWN. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS PERFORMED, AND THE RESULT WAS NORMAL. WHEN THE PUNCTURE NEEDLE WAS REMOVED, THE GUIDEWIRE REMAINED STUCK AND COULD NOT BE PULLED OUT. AS A RESULT, THE GUIDEWIRE WAS MANUALLY REMOVED AND FOUND TO BE INTACT AFTERWARD. IT WAS ALSO MENTIONED THAT THE GUIDEWIRE WAS NOT BROKEN INTO PIECES. THE GUIDEWIRE THAT WAS INCLUDED IN THE KIT WAS THE ONE USED, BUT IT WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. AFTER THE REPLACEMENT, THE NEW GUIDEWIRE WAS ABLE TO BE INSERTED AND USED WITHOUT ISSUE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE NEEDLE WAS NOT REPLACED, WHILE THE GUIDEWIRE WAS REPLACED WITH A NEW ONE AS THE REMEDIAL ACTION DONE BY THE SURGEON. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE OR CLEANING AGENT WAS APPLIED. THERE WERE NO LEAKS, AND TEGO WAS NOT UTILIZED. THE REPORTED CATHETER REMAINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323250 ↗
• MalfunctionJan 23, 2025Break; Break

  ACCORDING TO THE REPORTER BEFORE USE, THE CENTRAL VENOUS CATHETER FOR HEMODIALYSIS RUPTURED, SO THE PRODUCT WAS NOT USED AND WAS REPLACED BY THE MANUFACTURER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218053 ↗
• MalfunctionOct 22, 2024Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, AFTER CATHETERIZATION, THE CATHETER WAS DISLODGED FROM THE FIXATION WING, CAUSING CATHETER EXTUBATION. THE FIXED WINGS AND THE MAIN PART OF THE CATHETER FELL OFF. THERE WAS NO LEAK. IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED WITH THE SAME LOT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506797 ↗
• MalfunctionSep 10, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER HAD A LEAK AT THE JUNCTION OF THE EXTENSION TUBE AND BIFURCATE. THE CATHETER WAS NOT REPAIRED. THE CLEANING AGENT USED ON THE DEVICE WAS IODINE DISINFECTION. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE REMEDIAL ACTION DONE TO RESOLVE THE ISSUE WAS CATHETER REMOVAL, AND THE PRODUCT WAS REPLACED. THE TREATMENT WAS ABLE TO PROCEED AND WAS COMPLETED AFTER THE RESOLUTION. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS PROVIDED TO THE PATIENT DUE TO THE EVENT. THERE WERE 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 20182799 ↗
• MalfunctionJul 12, 2024Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AFTER THE PATIENT WAS INTUBATED AND PUT ON THE MACHINE, BLEEDING WAS FOUND AT THE VENOUS UPPER END OF EXTENSION TUBE. THE CATHETER HAD BEEN IN PLACE FOR ONE DAY. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE AND HAD NO ABNORMALITIES. THEY TIGHTEN THE ADAPTERS BY HAND ROUTINELY. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. TEGO WAS NOT UTILIZED. IODINE DISINFECTION WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS THE ONE TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT AT THE MOMENT. THEY PLACED A CATHETER AGAIN AS AN INTERVENTION IMMEDIATELY AND IN TIME ON THE NEXT DAY WITH THE SAME PRODUCT ID (IDENTIFIER), AND THEY CHECKED THE CONDITION OF THE TUBING CAREFULLY BEFORE CATHETER INSERTION AS A PRELIMINARY ACTION, AND THE TREATMENT WAS COMPLETED. THERE WAS A SMALL AMOUNT OF OOZING BLOOD. A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735812 ↗
• InjuryJun 29, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, A WEEK BEFORE THE EVENT OCCURRED, THE PATIENT UNDERWENT CATHETERIZATION TO THE RIGHT INTERNAL JUGULAR VEIN. THE PATIENT WAS PLACED IN THE SUPINE POSITION WITH THE SHOULDERS ELEVATED, AND ROUTINE DISINFECTION AND DRAPING WERE PERFORMED. LOCAL ANESTHESIA WAS PERFORMED WITH 2% LIDOCAINE. UNDER THE REAL-TIME GUIDANCE OF COLOR DOPPLER ULTRASOUND, THE TOP OF THE TRIANGLE FORMED BY THE STERNOCLEIDOMASTOID MUSCLE, CLAVICULAR HEAD, AND CLAVICLE ON THE RIGHT SIDE WAS TAKEN AS THE PUNCTURE POINT, AND THE PUNCTURE NEEDLE SUCCESSFULLY DREW VENOUS BLOOD. AFTER THE GUIDE WIRE WAS INSERTED AND THE SKIN WAS EXPANDED WITH A DILATOR, A DOUBLE-LUMEN CATHETER WAS PLACED INTO THE INTERNAL JUGULAR VEIN ALONG THE GUIDE WIRE, AND A 20-ML (MILLILITER) EMPTY NEEDLE WAS USED FOR ASPIRATION TO ENSURE SMOOTHNESS. A COLOR DOPPLER ULTRASOUND CONFIRMED THAT THE CATHETER WAS LOCATED IN THE INTERNAL JUGULAR VEIN. THE CATHETER WAS SEALED WITH HEPARIN SALINE, FIXED LOCALLY WITH SUTURES, AND COVERED WITH DRESSINGS. THE OPERATION WENT SMOOTHLY, AND THE PATIENT DID NOT COMPLAIN OF DISCOMFORT. THE PATIENT WAS INFORMED OF THE PRECAUTIONS AFTER THE OPERATION. ON THE SAME DAY, BEDSIDE CONTINUOUS HE

  Patient problems: Foreign Body In Patient

  MAUDE report 19640345 ↗
• MalfunctionJun 4, 2024Material Fragmentation; Misassembled; Unraveled Material; Material Fragmentation; Misassembled; Unraveled Material

  ACCORDING TO THE REPORTER, BEFORE THE CATHETER WAS INSERTED, THE WHOLE BODY OF THE GUIDE WIRE FELL OFF. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE, AND FLUSHING WAS NOT DONE. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE GUIDEWIRE THAT WAS INCLUDED IN THE KIT WAS THE ONE USED. THE GUIDEWIRE WAS UNRAVELED, AND THERE WAS NO EXCESSIVE FORCE USED ON THE GUIDEWIRE. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE DEVICE. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID AND LOT NUMBER ON THE SAME DAY OF THE EVENT TO RESOLVE THE GUIDEWIRE FALLING OFF ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458454 ↗
• MalfunctionApr 19, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT WITH CHRONIC KIDNEY DISEASE (STAGE 5) WENT TO THE CATHETERIZATION ROOM FOR RIGHT INTERNAL JUGULAR VEIN CATHETERIZATION AT 13:30. THE SURGERY WENT SMOOTHLY, THE DEPTH OF VEIN INSERTION WAS 13.5 CM (CENTIMETER), AND THE EXPOSED LENGTH OF THE CATHETER WAS 0 CM. THERE WAS NO BLEEDING OR EXUDATION AT THE PUNCTURE SITE, AND THERE WAS NO HEMATOMA ON THE SURROUNDING SKIN. THE DRESSING WAS DRY AND CLEAN, AND ICE WAS APPLIED TO THE PLACE WHERE THE CATHETER WAS INSERTED. THE PATIENT WAS ESCORTED TO THE RADIOLOGY DEPARTMENT FOR A CHEST X-RAY EXAMINATION AND THEN RETURNED TO THE WARD. HEMODIALYSIS TREATMENT WAS PERFORMED AT 15:00. 1 DAY AFTER THE CATHETER HAD BEEN IN PLACE, DURING THE EVALUATION BEFORE GETTING ON THE HEMODIALYSIS MACHINE, IT WAS FOUND THAT THERE WAS A LITTLE BLOOD STAIN ON THE PIPELINE WHICH MEANT EXTENSION TUBE. THE EXACT LOCATION OF THE LEAK ON THE CATHETER WAS THE BLUE EXTENSION TUBE NEAR THE ADAPTER. NO NEW BLOOD STAIN WAS FOUND AFTER DISINFECTION. AFTER THE HEMODIALYSIS MACHINE WAS PUT ON, THE PIPELINE WAS WRAPPED WITH 75% ALCOHOL GAUZE. WHEN THE HEMODIALYSIS MACHINE WAS PUT OFF AT 17:38, A SMALL AMOUNT OF BLOOD WAS FOUND ON THE DRESS

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

  MAUDE report 19144003 ↗
• MalfunctionDec 21, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DUE TO THROMBOSIS, THE PATIENT UNDERWENT TEMPORARY HEMOFILTRATION AND CATHETERIZATION, AND CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS PERFORMED AT THE BEDSIDE IN THE EMERGENCY ROOM. DURING CATHETERIZATION OR THE PROCESS OF PLACING THE CATHETER, THE COARSE TIP END OF THE THICK DILATOR HAD SPLIT OR CRACKED (BROKEN), AND THE SKIN COULD NOT BE EXPANDED. AS A PRELIMINARY ACTION, A HEMOFILTRATION TUBE WAS DIRECTLY USED TO EXPAND THE SKIN. IT WAS STATED THAT THERE WAS A DELAY IN TREATMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18376782 ↗
• InjuryDec 4, 2023Product Quality Problem; Migration; Product Quality Problem; Migration

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT WAS IMPLANTED WITH A CENTRAL VENOUS CATHETER VIA THE JUGULAR VEIN ON (B)(6), 2023. THE CATHETER BODY WAS FOUND TO BE SEPARATED FROM THE SUTURE WINGS FROM NORMAL USE UNTIL (B)(6), 2023, RESULTING IN THE CATHETER SLIPPING OUT, AND THE EXPOSED PORTION OF THE CATHETER BODY COULD NOT BE FIXED. IT WAS SAID THAT THE RING OF THE SUTURE WING FELL OFF BUT WAS NOT BROKEN AND THE STITCHES HELD. THERE WAS NO LEAK, AND THE CATHETER WAS NOT REPAIRED. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVE ON THE PRODUCT PRIOR TO USE AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE PRODUCT. CLEANING AGENT WAS NOT USED ON THE PRODUCT AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT IMPLANTATION. TEGO WAS NOT UTILIZED. FLUSHING WAS DONE WITH NORMAL RESULT. THE PROBLEMATIC CATHETER WAS REMOVED FOR THE PATIENT ON (B)(6), 2023, AND THE SAME CATHETER MODEL WAS REPLACED A DAY AFTER THE EVENT AS REMEDIAL ACTION AND MEDICAL INTERVENTION. THE PROCEDURE PROCEEDED AND COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THER

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 18263172 ↗
• MalfunctionJul 25, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING IMPLANTATION, THERE WAS A GUIDE WIRE FAILURE THAT CANNOT BE REMOVED. THE GUIDE WIRE WAS STUCK IN THE NEEDLE POSITION AND WAS INACCESSIBLE. AFTER REMOVAL, THE GUIDE WIRE WAS STILL INTACT (NO BREAKAGE), AND NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. IT WAS NECESSARY TO REMOVE BOTH THE WIRE GUIDE AND NEEDLE FROM THE PATIENT SIMULTANEOUSLY (ONCE) DUE TO A SO-CALLED MALFUNCTION. THE GUIDEWIRE WAS STILL INTACT WHEN IT WAS REMOVED. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED AND WAS REMOVED BY HAND. THE CATHETER WAS REPAIRED, AND THERE WAS NO LEAK. A REGULAR CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT USED, AND THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT IMPLANTATION. FLUSHING WAS PERFORMED PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS OR DAMAGES ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, AND THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE EVENT DID NOT REQUIRE INTERVENTION OR TREATMENT. THE PRODUCT WAS REPLACED ON THE SAME DAY AS A REMEDIAL ACTION, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND A B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391364 ↗
• MalfunctionJun 16, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE PATIENT NEEDED DIALYSIS AFTER CORONARY ANGIOGRAPHY, AND A LARGE FLOW/HIGH-FLOW TUBING PIPELINE FOR DIALYSIS WAS PUT IN PLACE (INDWELLED). DURING THE CATHETERIZATION PROCESS, THE GUIDE WIRE FAILED, GOT STUCK AT THE NEEDLE TIP, AND THE CATHETER COULD NOT ENTER. SO, AS A PRELIMINARY ACTION, THE CATHETER WAS URGENTLY REPLACED, AND ANOTHER NEW TUBE/CATHETER WAS REINSERTED. THERE WAS NO OBVIOUS HARM TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148836 ↗
• MalfunctionDec 27, 2022Product Quality Problem; Migration; Product Quality Problem; Migration

  ACCORDING TO THE REPORTER, THE PATIENT HAD NTC NON-TUNNELED HEMODIALYSIS CATHETER TEMPORARY CATHETERIZATION TO TREAT CHRONIC KIDNEY DISEASE FAILURE. IT WAS STATED THAT AT THE DATE OF THE EVENT THE PATIENT WAS FOR OUTPATIENT HEMODIALYSIS TREATMENT IN THE HEMODIALYSIS ROOM DEPARTMENT. AT 16:58, DURING DIALYSIS PREPARATION, THE NURSE IN THE HEMODIALYSIS ROOM OF THE DEPARTMENT CHANGED THE DRESSING AT THE FEMORAL VEIN CATHETERIZATION OF THE PATIENT'S RIGHT LOWER EXTREMITY. THE GAUZE COVERED BY THE FEMORAL VENOUS CATHETER OF THE PATIENT'S RIGHT LOWER EXTREMITY WAS OPENED AND IT WAS FOUND THAT THE FIXED BUTTERFLY WING OF THE FEMORAL VEIN HEMODIALYSIS CATHETER (THE PATIENT'S RIGHT LOWER EXTREMITY) WAS BROKEN (THE RING IN THE MIDDLE OF THE FIXED WING, THAT WAS ON THE SIDE CLOSE TO THE SKIN WAS BROKEN; LEFT AND RIGHT WING REMAINED STITCHED TO THE PATIENT), AND THIS WAS REPORTED TO THE RESIDENT PHYSICIAN. THE RESIDENT PHYSICIAN CHECKED THE PATIENT IMMEDIATELY AND FOUND THAT THE BUTTERFLY WING OF THE FEMORAL VEIN CATHETER WAS BROKEN, AND THE CATHETER PROTRUDED/DETACHED BY ABOUT 4CM. THE DRESSING AT THE PATIENT'S PLACING CATHETER SITE WAS CHANGED, AND THE CATHETER WAS FIXED TO PREVENT SLIPPAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16057621 ↗
• MalfunctionDec 7, 2022Migration; Migration

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN INTERNAL JUGULAR VEIN CATHETERIZATION FOR HEMODIALYSIS DUE TO UREMIA. ON (B)(6) THE PATIENT PULLED OUT THE JUGULAR VEIN CATHETER BY THEMSELVES. AT THAT TIME, HEMOSTASIS WAS IMMEDIATELY STOPPED/COMPRESSED BY THE PATIENT. THE JUGULAR VEIN CATHETER WAS INTACT AND THERE WAS NO DEFECT. IT COULD BE SEEN THAT THE INTERNAL JUGULAR VEIN FIXED SUTURE WAS INSTALLED ON THE SKIN. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15936998 ↗
• MalfunctionDec 7, 2022Product Quality Problem; Migration; Product Quality Problem; Migration

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN INTERNAL JUGULAR VEIN CATHETERIZATION FOR HEMODIALYSIS DUE TO UREMIA. THE PATIENT'S INTERNAL JUGULAR VEIN CATHETER AND FIXED SUTURE DEVICE MOVED OUT/MIGRATED FROM ITS POSITION. IT WAS SAID THAT THE STITCHES HELD. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. ARTIFICIAL LIVER LINK CIRCUIT WAS BEING UTILIZED WITH THE DEVICE. NO PART OF THE WING HAD FAILED AND THE RING OF THE SUTURE WING WAS NOT BROKEN. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE INTERNAL JUGULAR VEIN FIXATION SUTURE DEVICE AS WELL AS THE CATHETER WAS REMOVED AND THE PATIENT HAD A REINSERTION OF INTERNAL JUGULAR VEIN CATHETER AS PRELIMINARY ACTION. TREATMENT WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936939 ↗
• MalfunctionNov 22, 2022Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, THE PATIENT WAS EXPECTED TO BE TREATED FOR SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE. DURING THE CENTRAL VENOUS CATHETERIZATION, WHEN INSERTING THE NEEDLE AND GUIDEWIRE TO THE PATIENT, THE GUIDE WIRE GOT STUCK INSIDE THE NEEDLE. THE GUIDEWIRE AND THE NEEDLE WERE REMOVED SIMULTANEOUSLY/TOGETHER IN ONE ACTION FROM THE PATIENT. AFTER IT WAS TAKEN OUT FROM THE PATIENT, THERE WAS A KINKING/BENDING AND A GAP/SLIT (APPEARED AT THE BEND OF THE SPRING) DEFORMATION NOTED AT THE TIP (TOP END) OF THE GUIDEWIRE SPRING AND IT COULD NOT BE PULLED OUT INSIDE THE NEEDLE. IT WAS NOTED THAT GUIDEWIRE WAS STUCK DUE TO THE BENDING FROM ITS TIP. THERE WERE NO TOOLS USED WHEN TRYING TO REMOVE THE GUIDEWIRE. THE DIMENSIONS OF THE NEEDLE AND THE GUIDEWIRE MATCHED WITH WHAT WAS INDICATED ON THE LABEL AND NO NEEDLE DIMENSION ISSUE WAS NOTED. NO EXCESSIVE FORCE WAS USED DURING INSERTION/REMOVAL. THERE WAS A RESISTANCE WHEN ENTERING AND THEY IMMEDIATELY PULLED OUT THE NEEDLE TOGETHER. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED. THE GUIDEW IRE DID NOT BREAK. FLUSHING OF NEEDLE WAS DONE PRIOR TO USE. ALSO, PRIOR TO USE, ROUTINE PREPARATION WITHOUT CAREFUL OBSERVATION OF THE GUIDEWIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847997 ↗
• MalfunctionJan 7, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE MAIN TUBE OF CENTRAL VENOUS CATHETER WAS NOT UNOBSTRUCTED/NOT SMOOTH. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 13195232 ↗
• MalfunctionSep 15, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE BLUE TRANSPARENT SILICONE EPITAXIAL TUBE (JUNCTION OF THE EXTENSION TUBE AND THE LUER ADAPTER) HAD CRACKED AND THERE WAS BLOOD LEAK. THEY RE-INSERTED A CATHETER WITH THE SAME PRODUCT ID AND LOT AS INTERVENTION ON THE (B)(6) 2021. THE PROCEDURE WAS COMPLETED. IT WAS STATED THAT THE CLAMP WAS FIXED (NOT MOVING). THE FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS NORMAL. IT WAS ALSO MENTIONED THAT IT WAS IMPOSSIBLE TO JUDGE WHETHER THE RUPTURE OCCURRED BEFORE USE, BECAUSE WHEN THE DEVICE WAS PRE-FILLED BEFORE THE OPERATION, NO LEAKAGE WAS FOUND. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS A CLEANING AGENT (UNSPECIFIED BRAND) USED. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THEY TIGHTEN THE ADAPTERS BY HAND. THERE WAS BLOOD LOSS, BUT THE SPECIFIC AMOUNT OF BLOOD LOSS WAS NOT INFORMED. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476203 ↗
• MalfunctionSep 15, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ON (B)(6) 2021, THE PATIENT UNDERWENT ASEPTIC OPERATION OF THE RIGHT INTERNAL JUGULAR VEIN TEMPORARY DIALYSIS CATHETERIZATION, FOLLOWED BY REGULAR HEMODIALYSIS TREATMENT. ON (B)(6) 2021, THE PATIENT WAS UNDERGOING ROUTINE HEMODIALYSIS IN THE HEMODIALYSIS ROOM, WHEN THE NURSE OPENED THE DRESSING AT THE TEMPORARY CATHETERIZATION OF THE RIGHT INTERNAL JUGULAR VEIN, A CRACK AND LEAK WAS FOUND IN THE VENOUS END TUBE (PIPELINE WAS DAMAGED). IMMEDIATELY CLAMPED THE VENOUS ACCESS AND NOTIFIED THE DOCTOR. THE DAMAGED CATHETER WAS REMOVED AND REPLACED WITH THE NEW TEMPORARY DIALYSIS TUBE IN THE NECK. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED. AFTER REPLACEMENT, THE PATIENT COMPLETED THE DIALYSIS TREATMENT. FLUSHING WAS DONE PRIOR TO USE AND WAS UNOBSTRUCTED. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. THERE WERE OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12473910 ↗
• MalfunctionSep 7, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, IT WAS NOTED THAT BLOOD LEAK (HOLE/DAMAGE) WAS FOUND ON THE EXTENSION TUBE NEAR THE LUER ADAP TER(BLUE). THE CATHETER WAS NOT REPAIRED AND THE TUBE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED WITH THE PRODUCT PRIOR TO USE AND THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. IT WAS ALSO MENTIONED THAT FLUSHING WAS DONE PRIOR TO USE AND HAD A NORMAL RESULT. NO OTHER PRODUCT WAS USED WITH THE DEVICE. IT WAS ALSO STATED THAT THE CLAMP WAS MOVED PERIODICALLY AND A METAL CLAMP WAS NOT USED DURING INSERTION. THE CLEANING AGENT(S) WAS NOT MIXED AND SEPSIDERM WAS NOT USED TO CLEAN THE DEVICE. THE PATIENT DID NOT USED ANY TYPE OF CLEANING AGENT/ANTIBIOTIC ON THE CATHETER. THERE WERE NO PROTOCOL CHANGED TO THE RECENTLY USED CLEANERS. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT NEEDED. IT WAS ALSO STATED THAT THE MEDICAL INTERVENTION DONE WAS TO REMOVE THE CATHETER AND REPLACED WITH A NEW DEVICE. THE PROCEDURE WAS COMPLETED. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434453 ↗
• MalfunctionAug 12, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, WHEN THE BLOOD WAS DRAWN ON THE MACHINE, IT WAS FOUND THAT THERE WAS A BLOOD OOZING OUT OF THE CONNECTION BETWEEN THE VENOUS END OF THE CATHETER AND THE RUBBER MATERIAL, AND IT WAS DISCOVERED THAT THE CATHETER WAS BROKEN. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12315446 ↗
• MalfunctionNov 5, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE PATIENT WAS ON MAINTENANCE HEMODIALYSIS AND IT WAS NEEDED TO IN DWELL HEMOFILTRATION CATHETER. A RIGHT FEMORAL VEIN HEMOFILTRATION TUBE WAS PLACED UNDER BEDSIDE B-MODE ULTRASOUND POSITIONING AND THE RIGHT FEMORAL VEIN WAS PUNCTURED. DARK RED BLOOD WAS DRAWN BACK AND THE GUIDE WIRE WAS INSERTED THROUGH THE PUNCTURE NEEDLE. THE GUIDE WIRE WAS INSERTED ABOUT 10 TO 15 CENTIMETERS (CM) AND THE INSERTION WAS NOT SMOOTH AND THE RESISTANCE WAS LARGE. THE GUIDE WIRE WAS STUCK BACKWARDS AND IT WAS DIFFICULT TO PULL OUT. THE GUIDE WIRE WAS PULLED OUT TOGETHER WITH THE PUNCTURE NEEDLE AND COMPRESSION ON THE PUNCTURE POINT WAS DONE TO STOP THE BLEEDING. THE PUNCTURE BAG WAS REPLACED TO COMPLETE THE PUNCTURE CATHETERIZATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10790555 ↗

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-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-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-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-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-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
• 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