MAHURKAR 8888345629Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521006799), received between Feb 14, 2018 and Jun 12, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (7 reports).

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

31 other recalls cover devices cleared under the same FDA submission (K020089, 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. Jun 28, 2023Class IOpen, Classified

   Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

   Z-2388-2023 · Root cause: Process control · 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 12, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING THE INSERTION OF THE 3-LUMEN CATHETER (WHICH INCLUDED ONE MEDICATION LUMEN, ONE BROWN LUMEN, AND ONE WHITE LUMEN) OVER A GUIDEWIRE INTO THE JUGULAR VEIN, THROMBOSIS OCCURRED IN THE WHITE LUMEN (REFERRED TO AS THE "2-WAY SHILLEY LINE"). THE ISSUE SPECIFICALLY AFFECTED THE AUXILIARY LINE, WITH THE WHITE LUMEN SHOWING COMPLETE THROMBOSIS AND NO REFLUX, WHILE THE BROWN LUMEN FUNCTIONED NORMALLY. REVERSE FLUSHING AND ATTEMPTS TO CLEAR THE WHITE LUMEN USING SALINE AS A CLEANING AGENT WERE UNSUCCESSFUL, AS THERE WAS NO FLOW OR REFLUX. THE THROMBOSIS WAS OBSERVED AFTER GUIDEWIRE REMOVAL DURING FLOW AND REFLUX TESTING, AND NO ANTICOAGULANTS WERE USED IN RESPONSE. UPON REMOVAL, A THROMBUS (BLOOD) WAS FOUND NEAR THE VENOUS INSERTION OPENING. THE LINE WAS FLUSHED WITH SALINE BEFORE USE, AND ALL LUMENS WERE FUNCTIONING. NO OTHER PRODUCTS WERE USED TOGETHER WITH THE DEVICE. NO ABNORMALITY WAS OBSERVED IN THE PRODUCT BEFORE USE. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE IMPACT ON THE PATIENT WAS THE NEED FOR NEW ACCESS. THE CORRECTIVE ACTION DESCRIBED AS ¿NEED FOR NEW ACCESS¿ WAS PERFORMED, WITH A DOUBLE-LUMEN SHILLEY CATHETER INSERTED AND A CVC (

  Patient problems: Insufficient Information

  MAUDE report 22199296 ↗
• MalfunctionMay 22, 2025Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, A VENOUS PUNCTURE WAS PERFORMED WITH THE INTRODUCTION OF THE GUIDE WIRE, FOLLOWED BY THE REMOVAL OF THE NEEDLE. THE PATH WAS DILATED WITH THE DILATOR, WHICH WAS THEN REMOVED. THE CATHETER WAS INSERTED PROPERLY, AND, SUBSEQUENTLY, THE GUIDE WIRE WAS REMOVED. THE FLOW AND REFLUX TEST OF THE CATHETER ROUTES WAS CARRIED OUT, WITH PATENCY OBSERVED IN ONLY ONE OF THE THREE ROUTES. A NEW IRRIGATION ATTEMPT WAS MADE, WITHOUT SUCCESS IN THE OBSTRUCTED WATERWAYS. GIVEN THE FUNCTIONAL FAILURE, IT WAS DECIDED TO REMOVE THE CATHETER. ON VISUAL EXAMINATION, A THROMBUS WAS OBSERVED ATTACHED TO THE DISTAL END OF THE DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22075561 ↗
• MalfunctionMar 1, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING THE USAGE ON THE THIRD ROUTE OF DIALYSIS CATHETER, IT BROKE. THIS OCCURRED IN TWO DIFFERENT CATHETERS. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE MEASURE ADOPTED WAS TO CHANGE THE DIALYSIS CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16461940 ↗
• MalfunctionJan 6, 2023Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE ACTUAL INSERTION OF A TRIPLE LUMEN HEMODIALYSIS CATHETER, WHEN THE CATHETER IS BEING THREAD THROUGH THE GUIDEWIRE AS PER SELDINGER TECHNIQUE FOR INSERTION, THE GUIDEWIRE WHICH WAS SUPPOSED TO EXIT OUT OF THE 3RD LUMEN (I.E. THE INFUSION PORT), CAME OUT OF THE BLUE DIALYSIS PORT. THERE WAS NO LUER ADAPTER ISSUE. THE PROCEDURISTS NOTICED THAT IT WAS A DIFFERENT MODEL THAN THE USUAL CATHETER. TEGO WAS UTILIZED ON THE REPORTED PRODUCT. FLUSHING WAS DONE PRIOR TO USE AND THERE WERE NO ISSUES PRIOR TO INSERTION AND IMMEDIATELY POST INSERTION WHILE CHECKING FOR PATENCY. THE CLEANING AGENT USED ON THE REPORTED PRODUCT AS PER HOSPITAL PROTOCOL WAS HEXANOL SKIN DISINFECTANT PRIOR TO INSERTION AND ON ALSO AT THE INSERTION SITE DURING DRESSING CHANGE. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE REPORTED PRODUCT AND NO EXCESSIVE FORCE WAS USED ON THE PRODUCT. AS A REMEDIAL ACTION REINSERTION WAS DONE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16118647 ↗
• MalfunctionJan 6, 2023Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE ACTUAL INSERTION OF A TRIPLE LUMEN HEMODIALYSIS CATHETER, WHEN THE CATHETER IS BEING THREAD THROUGH THE GUIDEWIRE AS PER SELDINGER TECHNIQUE FOR INSERTION, THE GUIDEWIRE WHICH WAS SUPPOSED TO EXIT OUT OF THE 3RD LUMEN (I.E. THE INFUSION PORT) CAME OUT OF THE BLUE DIALYSIS PORT. THERE WAS NO LUER ADAPTER ISSUE. THE PROCEDURISTS NOTICED THAT IT WAS A DIFFERENT MODEL THAN THE USUAL CATHETER. TEGO WAS UTILIZED ON THE REPORTED PRODUCT. FLUSHING WAS DONE PRIOR TO USE AND THERE WERE NO ISSUES PRIOR TO INSERTION AND IMMEDIATELY POST INSERTION WHILE CHECKING FOR PATENCY. THE CLEANING AGENT USED ON THE REPORTED PRODUCT AS PER HOSPITAL PROTOCOL WAS HEXANOL SKIN DISINFECTANT PRIOR TO INSERTION AND ON ALSO AT THE INSERTION SITE DURING DRESSING CHANGE. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE REPORTED PRODUCT AND NO EXCESSIVE FORCE WAS USED ON THE PRODUCT. AS A REMEDIAL ACTION REINSERTION WAS DONE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16118635 ↗
• MalfunctionJan 6, 2023Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE ACTUAL INSERTION OF A TRIPLE LUMEN HEMODIALYSIS CATHETER, WHEN THE CATHETER IS BEING THREAD THROUGH THE GUIDEWIRE AS PER SELDINGER TECHNIQUE FOR INSERTION, THE GUIDEWIRE WHICH WAS SUPPOSED TO EXIT OUT OF THE 3RD LUMEN (I.E. THE INFUSION PORT), CAME OUT OF THE BLUE DIALYSIS PORT. THERE WAS NO LUER ADAPTER ISSUE. THE PROCEDURISTS NOTICED THAT IT WAS A DIFFERENT MODEL THAN THE USUAL CATHETER. TEGO WAS UTILIZED ON THE REPORTED PRODUCT. FLUSHING WAS DONE PRIOR TO USE AND THERE WERE NO ISSUES PRIOR TO INSERTION AND IMMEDIATELY POST INSERTION WHILE CHECKING FOR PATENCY. THE CLEANING AGENT USED ON THE REPORTED PRODUCT AS PER HOSPITAL PROTOCOL WAS HEXANOL SKIN DISINFECTANT PRIOR TO INSERTION AND ON ALSO AT THE INSERTION SITE DURING DRESSING CHANGE. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE REPORTED PRODUCT AND NO EXCESSIVE FORCE WAS USED ON THE PRODUCT. AS A REMEDIAL ACTION REINSERTION WAS DONE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16118625 ↗
• MalfunctionJan 6, 2023Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE ACTUAL INSERTION OF A TRIPLE LUMEN HEMODIALYSIS CATHETER, WHEN THE CATHETER IS BEING THREAD THROUGH THE GUIDEWIRE AS PER SELDINGER TECHNIQUE FOR INSERTION, THE GUIDEWIRE WHICH WAS SUPPOSED TO EXIT OUT OF THE 3RD LUMEN (I.E. THE INFUSION PORT), CAME OUT OF THE BLUE DIALYSIS PORT. THERE WAS NO LUER ADAPTER ISSUE. THE PROCEDURISTS NOTICED THAT IT WAS A DIFFERENT MODEL THAN THE USUAL CATHETER. TEGO WAS UTILIZED ON THE REPORTED PRODUCT. FLUSHING WAS DONE PRIOR TO USE AND THERE WERE NO ISSUES PRIOR TO INSERTION AND IMMEDIATELY POST INSERTION WHILE CHECKING FOR PATENCY. THE CLEANING AGENT USED ON THE REPORTED PRODUCT AS PER HOSPITAL PROTOCOL WAS HEXANOL SKIN DISINFECTANT PRIOR TO INSERTION AND ON ALSO AT THE INSERTION SITE DURING DRESSING CHANGE. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE REPORTED PRODUCT AND NO EXCESSIVE FORCE WAS USED ON THE PRODUCT. IT WAS STATED THAT THE INCIDENT FILED WERE NOT PRODUCT COMPLAINTS, BUT RATHER A PRACTICE CHANGE. THE HOSPITAL RECENTLY SWITCHED FROM ELITE TO LEGACY MODELS. AS A REMEDIAL ACTION REINSERTION WAS DONE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16118616 ↗
• MalfunctionJan 6, 2023Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON A CLEAN CATHETER OF THE SAME LOT THAT HAD THE GUIDEWIRE COME OUT OF THE BLUE PORT. IT WAS STATED THAT THERE WAS A COMMUNICATING TRACK BETWEEN THE TIP OF THE CATHETER AND DIALYSIS EYE OF THE CATHETER (THE LUMENS SHOULD BE SEPARATED). THE GUIDEWIRE WAS USED AND THREADED IN TO SEE THE TRACK AND THAT IS WHEN THE COMMUNICATING TRACK WAS DISCOVERED, AND A PICTURE WAS TAKEN. THIS WAS NOT DONE IN CLINICAL PRACTICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16115347 ↗
• MalfunctionJan 3, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE PASSING PROCEDURE, THE GUIDEWIRE FELL APART. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090968 ↗
• MalfunctionJan 3, 2023Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE ACTUAL INSERTION OF A TRIPLE LUMEN HEMODIALYSIS CATHETER, WHEN THE CATHETER WAS BEING THREAD THROUGH THE GUIDEWIRE AS PER SELDINGER TECHNIQUE FOR INSERTION, THE GUIDEWIRE WHICH WAS SUPPOSED TO EXIT OUT OF THE 3RD LUMEN (I.E. THE INFUSION PORT), CAME OUT OF THE BLUE DIALYSIS PORT. THERE WAS NO LEAK, AND NO LUER ADAPTER ISSUE. THE PROCEDURISTS NOTICED THAT IT WAS A DIFFERENT MODEL THAN THE USUAL CATHETER. FLUSHING WAS DONE PRIOR TO USE AND THERE WERE NO ISSUES PRIOR TO INSERTION AND IMMEDIATELY POST INSERTION WHILE CHECKING FOR PATENCY. THE CLEANING AGENT USED ON THE REPORTED PRODUCT AS PER HOSPITAL PROTOCOL WAS HEXANOL SKIN DISINFECTANT PRIOR TO INSERTION AND ON ALSO AT THE INSERTION SITE DURING DRESSING CHANGE. THE INSERTION SITE WAS CLEANED AS PER HOSPITAL PROTOCOLS FOR ASEPTIC TECHNIQUE PRIOR TO PRODUCT PLACEMENT, TEGO WAS UTILIZED, THERE WERE NO OTHER PRODUCT UTILIZED WITH THE REPORTED PRODUCT AND EXCESSIVE FORCE WAS NOT USED ON THE PRODUCT. THE CATHETER WAS NOT REPAIRED. THE GUIDE WIRE WAS REMOVED BY HAND. IT WAS NOT NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088142 ↗
• MalfunctionApr 12, 2022Material Puncture/Hole; Product Quality Problem; Insufficient Flow or Under Infusion; Material Puncture/Hole; Product Quality Problem; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE CATHETER HAD 4 HOLES DESPITE BEING TRIPLE LUMEN. IT WAS MENTIONED THAT THE DISTAL ROUTE WAS THE VENOUS ROUTE AND HAD COMMUNICATION WITH THE MEDIAL ORIFICE. ARTERIAL AND VENOUS ROADS WITH MEMORY, MAKING IT DIFFICULT TO EXIT THE GUIDE WIRE DURING INSERTION, ALSO HINDERED FLOW IN FEMORAL INSERTION DURING THE HEMODIALYSIS PROCEDURE. THE PRODUCT USE FOLLOWED THE MANUFACTURER'S INSTRUCTIONS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 14086830 ↗
• MalfunctionOct 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, THE HEMODIALYSIS CATHETER WAS INSERTED IN HOSPITAL BED NO. 53. DURING USE, IT WAS SAID THAT THE FLEXIBLE CATHETER WAS TWISTED AND COILED/BENT WITH THE PRESSURE OF THE COMPETITOR MACHINE AND CAUSED IT TO HAVE A CONSTANT ALARM DUE TO A LINE/ACCESS AND FLOW ISSUES. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THE CATHETER HAD TO BE CHANGED TO SEQUENCE THE DIALYTIC TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12646701 ↗
• MalfunctionSep 13, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE THIRD WAY OF THE CATHETER MUST EXIT AT THE END (AFTER THE EXIT OF THE FIRST AND SECOND WAY) TO ENABLE THE ADMINISTRATION OF THE DRUG, BUT THE OUTPUT OF THE THIRD WAY OF THIS MATERIAL WAS QUESTIONABLE. THEREFORE, THE DRUG ADMINISTERED RECIRCULATED IN THE MACHINE AND DID NOT GO DIRECTLY TO THE PATIENT. IN ADDITION, THE GUIDEWIRE EXIT WOULD BE THROUGH THIS ROUTE, WHICH DID NOT HAPPEN. THE USE OF THE PRODUCT FOLLOWED THE INSTRUCTIONS OF THE MANUFACTURING SERVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12458919 ↗
• MalfunctionAug 10, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AT INSERTION INTO THE PATIENT'S LEFT SUBCLAVIAN ARTERY USING SKDINGER TECHNIQUES, THE PATIENT WAS IN A SUPINE POSITION, LAYING ON THE STERILE FIELDS, AND HAD LOCAL ANESTHESIA INFILTRATED WITH XYLOCAINE 2% WITHOUT VASOCONTRICTOR, THE GUIDE WIRE WAS STUCK IN THE CATHETER. IT DID NOT LEAVE WITHOUT REMOVING THE CATHETER (IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY). THE GUIDE WIRE WAS STILL INTACT WHEN IT WAS REMOVED. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. ASEPSIS AND ANTISEPSIS WITH ALCOHOLIC CHLORHEXIDINE 0.5% WAS USED AS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS OBSERVATION OF BLOOD REFLUX THROUGH THE EQUIPMENT AND HAD FIXATION OF THE CATHETER WITH MONONYLON WIRE 3-0. THERE WAS OCCLUSIVE DRESSING AND PRESCRIPTION (RX) CONTROL REQUEST (INDICATION FOR DIALYSIS). THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS DONE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION AND THERE WAS NO OCCLUSION. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302263 ↗
• InjuryMay 20, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AFTER THE SUCCESSFUL PUNCTURE OF THE CVC (CENTRAL VENOUS CATHETER) IN THE JUGULAR VEIN, WHEN REMOVING THE PATIENT'S GUIDEWIRE, IT WAS STUCK INSIDE THE VEIN WITH ABOUT 20 CM (CENTIMETER) AND IN NEED OF SURGICAL INTERVENTION FOR THE REMOVAL OF THE GUIDEWIRE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. IT DID NOT LEAD TO HEATH PROBLEMS, THERE WAS NO PERMANENT INJURY, THERE WAS NO BLEEDING, BLOOD TRANSFUSION WAS NOT REQUIRED, THERE WAS AN INCREASE OF SURGICAL TIME, AND THE EVENT DID NOT PROLONG THE HOSPITALIZATION. THE PROCEDURE WAS COMPLETED, THE DEVICE WAS NOT REPLACED, THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, AND THE ADDITIONAL SURGICAL INTERVENTION OCCURRED AT THE PATIENT'S SCHEDULE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854621 ↗
• MalfunctionMay 14, 2021Material Frayed; Infusion or Flow Problem; Material Frayed; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE HEMODIALYSIS CATHETER HAD A FAILURE. IT WAS MENTIONED THAT THERE WAS BLEEDING AT THE APPLICATION SITE, BREAKAGE OF THE GUIDE WIRE, AND INADEQUATE FLOW OF BLOOD SUPPLY. THE USE OF THE PRODUCT FOLLOWED THE INSTRUCTIONS OF THE MANUFACTURING SERVICE AND THERE WERE NO PRODUCT CHANGES. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11824531 ↗
• MalfunctionSep 4, 2018Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, POST- OPERATIVELY, THERE WAS A LOW FLOW PERFORMANCE AND CATHETER OBSTRUCTION OR NO FLOW AT THE LUMEN. FLUSHING WAS PERFORMED PRIOR TO INSERTION OBTAINING A BELOW-EXPECTED RESULTS. IT WAS STATED THAT THEY TRIED TO INVERT THE LINES BUT TO NO AVAIL AND THEY COULDN'T PERFORM THE WASH WITH THE SYRINGE. IT WAS ALSO STATED THAT AN HEPARIN WAS USED AS ANTI-COAGULANT. THE DIALYSIS WAS NOT PERFORMED DUE TO LACK OF CATHETER FLOW. IT WAS REPORTED THAT THERE WAS NO PERMANENT INJURY TO THE PATIENT AND THE PATIENT WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7842264 ↗
• MalfunctionAug 17, 2018Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE GUIDE WIRE WAS SHOWING RESISTANCE INSIDE THE CATHETER. IT WAS REPORTED THAT WHEN PULLED, IT BEGAN TO DISINTEGRATE, UNDOING, AND UNSUCCESSFUL IN REMOVAL. IT WAS INDICATED THAT THERE WAS A NEED FOR REMOVAL OF THE CATHETER ASSOCIATED WITH THE GUIDE WIRE OF THE VEIN AND NEW WAS NEEDED TO PUNCTURE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793210 ↗
• MalfunctionJul 31, 2018Obstruction of Flow; Deformation Due to Compressive Stress; Infusion or Flow Problem; Material Twisted/Bent; Material Too Soft/Flexible; Deformation Due to Compressive Stress; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS AN OBSTRUCTION OF FLOW CAUSED BY A TWIST OF THE CATHETER THAT HAS A MORE FLEXIBLE AND SOFT MATERIAL. THIS TORSION CAUSED PERMANENT CREASE WITHOUT IMPROVEMENT WITH CORRECT POSITIONING OF THE CATHETER. IT WAS STATED THAT THERE WAS AN INCREASE IN CASES DUE TO THIS MECHANICAL PROBLEM OF THE CATHETER. FOR THIS REASON, PATIENTS EXPERIENCED MORE FREQUENT CATHETER CHANGES AS WELL AS INCREASED CATHETER MANIPULATION AND INCREASED RISK OF INFECTION.

  Patient problems: No Code Available; No Information

  MAUDE report 7737276 ↗
• MalfunctionJul 20, 2018Mechanical Problem; Obstruction of Flow; Deformation Due to Compressive Stress; Infusion or Flow Problem; Material Twisted/Bent; Deformation Due to Compressive Stress; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS AN OBSTRUCTION OF FLOW CAUSED BY THE TWIST OF THE CATHETER THAT HAS A MORE FLEXIBLE AND SOFT MATERIAL. THIS TORSION CAUSED PERMANENT CREASE WITHOUT IMPROVEMENT WITH CORRECT POSITIONING OF THE CATHETER. IT WAS STATED THAT THERE WAS AN INCREASE IN CASES DUE TO THIS MECHANICAL PROBLEM OF THE CATHETER. FOR THIS REASON, PATIENTS EXPERIENCED MORE FREQUENT CATHETER CHANGES AS WELL AS INCREASED CATHETER MANIPULATION AND INCREASED RISK OF INFECTION.

  Patient problems: No Code Available; No Information

  MAUDE report 7706664 ↗
• MalfunctionJul 20, 2018Obstruction of Flow; Deformation Due to Compressive Stress; Infusion or Flow Problem; Deformation Due to Compressive Stress; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS AN OBSTRUCTION OF FLOW CAUSED BY THE TWIST OF THE CATHETER THAT HAS A MORE FLEXIBLE AND SOFT MATERIAL. THIS TORSION CAUSED PERMANENT CREASE WITHOUT IMPROVEMENT WITH CORRECT POSITIONING OF THE CATHETER. IT WAS STATED THAT THERE WAS AN INCREASE IN CASES DUE TO THIS MECHANICAL PROBLEM OF THE CATHETER. FOR THIS REASON, PATIENTS EXPERIENCED MORE FREQUENT CATHETER CHANGES AS WELL AS INCREASED CATHETER MANIPULATION AND INCREASED RISK OF INFECTION.

  Patient problems: No Code Available; No Information

  MAUDE report 7706381 ↗
• MalfunctionFeb 14, 2018Difficult to Advance; Infusion or Flow Problem; Difficult to Advance; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE DEVICE WAS VERY FLEXIBLE AND FOLDED DECREASING FLOW DURING DIALYSIS. THE GUIDE WIRE WAS FRAGILE MAKING IT DIFFICULT TO ADVANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7270354 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020089, 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-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-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-2387-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
• Z-2375-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
• Z-2377-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
• Z-2386-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
• Z-2379-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
• Z-2389-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP
• Z-2391-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
• Z-2373-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
• Z-2378-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629

…and 16 more.