MAHURKAR 8888135162Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521006379), received between Feb 2, 2018 and Jul 12, 2024 — classified as 1 death, 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2024Product Quality Problem; Difficult to Remove; Unraveled Material; Product Quality Problem; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING INSERTION, THE GUIDE WIRE WAS KINKED AT MID-SECTION AND COULD NOT BE USED. THERE WAS RESISTANCE WHEN INSERTING THE GUIDE WIRE. THE GUIDE WIRE WAS STUCK. THE GUIDE WAS UNRAVELED. THE GUIDE WIRE DID NOT BREAK INTO PIECES. THE GUIDE WIRE USED THE ONE INCLUDED IN THE KIT. THE DIMENSION OF THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. THERE WAS NO DIMENSION ISSUE NOTED. NO EXCESSIVE FORCE APPLIED ON THE PRODUCT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING USED ON THE DEVICE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS NORMAL. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED WITH THE SAME LOT ON THE SAME DAY, RE-INTUBATION REQUIRED AS INTERVENTION AS A RESULT OF THE EVENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT HAD NO VESSEL DAMAGE DUE TO THE EVENT WITH THE KINKED GUIDE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19732078 ↗
• MalfunctionMay 13, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PREOPERATIVE CATHETER FLUSHING REVEALED SMALL HOLES IN THE ARTERY EXTENSION TUBE. IT WAS NOTED THAT THERE WAS A LEAK AT THE BIFURCATE. THERE WAS UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE WHICH WAS WATER LEAKAGE AND FOUND THAT THERE WERE HOLES IN THE SILICONE OF THE ARTERY CONNECTOR. THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO DAMAGE TO THE EXTERNAL PACKAGING AND NO DAMAGE TO THE PRODUCT'S BOX. THERE WERE NO EXCESSIVE FORCE USED ON THE DEVICE. CLAMP AND CLEANING AGENT WERE NOT USED AS THE REPORTED PRODUCT WAS NOT USED. AS A REMEDIAL ACTION, THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID AND LOT ON THE SAME DAY OF THE EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305035 ↗
• MalfunctionApr 12, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING SALINE PRE-FILL, THERE WAS A LEAK AT THE EXTENSION TUBE (ARTERIAL SIDE) AND BIFURCATION CONNECTION. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING/PRIMING WAS DONE PRIOR TO USE AND NO PROBLEM WAS FOUND. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER PROBLEM. IODOPHOR WAS USED AS THE CLEANING AGENT ON THE DEVICE. ALCOHOL-FREE SANITIZED IODOPHOR WAS NOT UTILIZED TO CLEAN THE ADAPTERS AND NO OINTMENT WAS APPLIED. THE INSERTION SITE TREATED WITH PRIOR TO PRODUCT PLACEMENT. CATHETER WAS NOT REPAIRED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE APPLIED ON THE DEVICE AND NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE CATHETER WAS EXPLANTED AND REPLACED WITH A PRODUCT FROM ANOTHER MANUFACTURE AS A REMEDIAL ACTION TO RESOLVE THE ISSUE. THERE WAS A 50 MILLILITER (ML) BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT PROVIDED TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19099663 ↗
• MalfunctionApr 21, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT AFTER THE OPERATION, IT WAS FOUND THAT THERE WAS A BLOOD LEAK LOCATED AT THE VENOUS SILICONE EXTENSION TUBE NEAR THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT PERFORMED PRIOR TO USE. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED, AND THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE AND ON THE ADAPTER WAS IODOPHOR. THE INSERTION SITE WAS TREATED WITH IODOPHOR PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE CLAMP WAS MOVED PERIODICALLY, AND THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CATHETER HAD BEEN IN PLACE ON THE DAY OF THE IMPLANTATION, AND IT WAS REPLACED ON THE SAME DAY OF THE EVENT TO RESOLVE THE ISSUE. THE TREATMENT WAS COMPLETED. THERE WAS AN UNKNOWN AMOUNT OF BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16790942 ↗
• MalfunctionMar 31, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN TESTING THE BLOOD FLOW WHEN THE PATIENT WAS READY TO BE DRAINED AFTER THE IV CATHETER WAS INSERTED, MINOR VENOUS EXTENSION TUBE BREAKAGE NEAR THE CLAMPED PART (SMALL HOLE) WAS FOUND AND BLOOD WAS OOZING WHEN PUSHING QUICKLY. THERE WAS BLOOD LEAK. IT WAS DISCONTINUED AND THEY NOTIFIED THE DOCTOR IMMEDIATELY AND REPLACED THE CATHETER IN TIME BUT IT DID NOT RESOLVE THE ISSUE. THE CATHETER WAS NOT REPAIRED AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE AND ITS ENTIRETY. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. ANLE IODINE WAS THE CLEANING AGENT USED TO CLEAN THE ADAPTERS AND THEY DID NOT APPLY OINTMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THE CATHETER WAS REMOVED TO RESOLVE THE ISSUE. PROCEDURE WAS NOT COMPLETED. BLOOD TRA NSFUSION WAS NOT REQUIRED. IMMEDIATELY UPON DISCOVERY OF THE EVENT, THE SUPPLIES AND EQUIPMENT OFFICE FOR REPORTING AND SUBSEQUENT PROCESSING WAS NOTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658729 ↗
• MalfunctionJun 27, 2022Product Quality Problem; Migration; Product Quality Problem; Migration

  ACCORDING TO THE REPORTER, THE CATHETER DISLODGED FROM THE SUTURE WING. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED WITH PRIOR TO PRODUCT PLACEMENT, THE CLEANING AGENT USED ON THE DEVICE WAS STERI PREP, AND TEGO WAS NOT UTILIZED. THE CATHETER WAS NOT REPAIRED. 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 14831541 ↗
• MalfunctionJan 7, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHEN THE PUNCTURE NEEDLE HAD BEEN INSERTED INTO THE PATIENT'S BODY AND WHEN THE GUIDE WAS INSERTED AFTER THE PUNCTURE, THE GUIDE WIRE WAS STUCK INSIDE THE PUNCTURE NEEDLE AND COULD NOT BE PULLED. THE GUIDE WIRE WAS STILL ATTACHED TO THE PUNCTURE NEEDLE (BASED ON THE FILM). THE PRODUCT WAS REPLACED WITH THE SAME LOT ON THE SAME DAY OF THE EVENT, THE GUIDE WIRE AND PUNCTURE NEEDLE IN THE FIRST KIT WERE THE ONLY ONES THAT REPLACED, WHILE THE CATHETER IN THE FIRST KIT WAS STILL IN USE AND THE PROCEDURE/TREATMENT WAS COMPLETED. NO TOOLS USED TO REMOVE THE GUIDE WIRE, NO EXCESSIVE FORCE REQUIRED TO REMOVE THE GUIDE WIRE WITH THE PUNCTURE NEEDLE, THE GUIDE WAS STILL INTACT, NO DAMAGE SEEN ON THE GUIDE WIRE AND THERE WAS NO VISIBLE DEFECT/DAMAGE NOTED WITH THE NEEDLE. THE DIMENSION OF THE NEEDLE AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. NO PROBLEM WITH THE GUIDE WIRE FOUND IN THE PACKAGE, NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE PRIOR TO USE AND NO ABNORMALITY FOUND. THE GUIDE WIRE AND NEEDLE USED WERE THE ONES INCLUDED IN THE KIT. NO DEFECTS/DAMAGES FOUND ON THE CATHETER ITSELF. NO OTHER PRODUCTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193943 ↗
• MalfunctionJan 6, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AFTER THE PATIENT WAS CATHETERIZED AND DURING DIALYSIS, IT WAS FOUND THAT THE ARTERIAL EXTENSION TUBE NEAR THE LUER ADAPTER WAS DAMAGED (HAS A HOLE) AND HAD LEAKED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE WITH NORMAL RESULT AND NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CATHETER WAS NOT REPAIRED AND IT WAS REPLACED TO RESOLVE THE ISSUE. PROCEDURE WAS COMPLETED. THE PATIENT HAD HEPATITIS B AND THE SAMPLE WAS DISCARDED BY THE HOSPITAL. THERE WAS A BLOOD LOSS OF ABOUT 5ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176325 ↗
• MalfunctionJan 4, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE DIALYSIS TREATMENT, BLOOD LEAKED AT THE JUNCTION OF THE VENOUS LUER ADAPTER AND THE SILICONE EXTENSION TUBE. THE CATHETER WAS NOT REPAIRED AND NORMAL SALINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH NORMAL SALINE AND IODOPHOR COTTON BALLS. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE AND NO ABNORMALITY WAS FOUND. FROM THE TIME THE CATHETER WAS IMPLANTED (IMPLANTED A DAY BEFORE THE EVENT) UP TO THE TIME THE ISSUE OCCURRED, THE CLAMP WAS MOVED PERIODICALLY. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE AND IT HAD A TINY HOLE WHERE THE LEAK WAS OBSERVED. THERE WAS NO EXCESSIVE FOR USED ON THE PRODUCT. THERE WAS NO BLOOD LOSS AND THE PRODUCT WAS REPLACED WITH A NEW ONE ON THE SAME DAY OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152765 ↗
• MalfunctionSep 13, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AFTER PUNCTURE, WHEN THE GUIDE WIRE WAS INTRODUCED, THE GUIDE WIRE WAS STUCK IN THE MIDDLE OF THE PUNCTURE NEEDLE WITHOUT BLOOD LOSS. THE GUIDE WIRE WAS NOT STUCK IN THE PATIENT'S BODY. AFTER TAKING OUT, THE GUIDE WIRE WAS STILL INTACT. NO TOOLS USED TO REMOVE THE GUIDE WIRE. THEY DID NOT REMOVE THE GUIDE WIRE FROM THE NEEDLE AS IT COULD NOT BE TAKEN OUT (BASED ON THE FILM). THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID AND LOT ON THE DAY OF THE EVENT. THE PROCEDURE WAS COMPLETED. NO VISIBLE DEFECT/DAMAGE NOTED WITH THE NEEDLE. THE GUIDE WIRE AND NEEDLE USED WERE THE ONES INCLUDED IN THE KIT. THE DIMENSION OF THE NEEDLE AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. THE FLUSHING OF THE NEEDLE WAS NORMAL WITHOUT UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED WITHOUT OTHER DEFECTS/DAMAGES AND WITHOUT OTHER PRODUCTS BEING UTILIZED. THERE WAS NO LEAK. NO CLEANING AGENT USED ON THE DEVICE. IODOPHOR WAS USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO OTHER INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460469 ↗
• MalfunctionJan 18, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  ACCORDING TO THE REPORTER, THE GUIDE WIRE WAS BENT AND STUCK IN THE CATHETER DURING THE OPERATION/INSERTION ON THE PATIENT AND THE OPERATION WAS NOT COMPLETED. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE TOGETHER (AT THE SAME TIME) WITH THE CATHETER. THEY SLOWLY REMOVED THE GUIDE WIRE WITH A LITTLE FORCE. NO TOOLS USED WHEN TRYING TO REMOVE THE GUIDEWIRE. WHEN REMOVED, THE GUIDEWIRE WAS STILL INTACT. THE GUIDEWIRE PROVIDED WITH THE KIT WAS BEING USED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE GUIDE WIRE WAS INTACT WHEN THE PACKAGE WAS OPENED. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS SMOOTH. THERE WAS BLOOD LOSS OF ABOUT 5ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE DEVICE WAS NOT REPAIRED. NO CLEANING AGENT USED ON THE DEVICE. THEY REPLACED OR ADOPTED OTHER TREATMENT PLANS/OPTIONS AND SURGICAL METHOD BY CHANGING THE FEMORAL VEIN CANNULA AND REPLACING THE DEVICE TO USE ANOTHER COMPETITOR'S PRODUCT. THE ISSUE WAS RESOLVED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 11187760 ↗
• MalfunctionJan 18, 2021Difficult to Remove; Difficult to Advance; Insufficient Device Problem Information; Difficult to Remove; Difficult to Advance; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE GUIDE WIRE WAS BENT AND STUCK IN THE CATHETER DURING THE OPERATION/INSERTION ON THE PATIENT AND THE OPERATION WAS NOT COMPLETED. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE TOGETHER (AT THE SAME TIME) WITH THE CATHETER. THEY SLOWLY REMOVED THE GUIDE WIRE WITH A LITTLE FORCE. NO TOOLS USED WHEN TRYING TO REMOVE THE GUIDEWIRE. WHEN REMOVED, THE GUIDEWIRE WAS STILL INTACT. THE GUIDEWIRE PROVIDED WITH THE KIT WAS BEING USED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE GUIDE WIRE WAS INTACT WHEN THE PACKAGE WAS OPENED. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS SMOOTH. THERE WAS BLOOD LOSS OF ABOUT 5ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE DEVICE WAS NOT REPAIRED. NO CLEANING AGENT USED ON THE DEVICE. THEY REPLACED OR ADOPTED OTHER TREATMENT PLANS/OPTIONS AND SURGICAL METHOD. THE PRODUCT WAS REPLACED WITH ANOTHER COMPETITOR'S PRODUCT TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11187079 ↗
• DeathDec 22, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING INSERTION OF THE CATHETER, CATHETER WAS INSTALLED WITHOUT DIFFICULTY. HOWEVER, WHEN TRYING TO REMOVE THE GUIDE WIRE GENTLY, IT WAS DIFFICULT TO REMOVE. THE SAME MANEUVER WITH A LITTLE MORE FORCE WAS PERFORMED BUT WITHOUT SUCCESS. THE CATHETER AND GUIDE WIRE WERE REMOVED TOGETHER. IT WAS DECIDED TO TRY AGAIN WITH A NEW CATHETER BUT SAME ISSUE OCCURRED. EVEN IN THE FACE OF THE SECOND MANEUVER OF REMOVAL OF THE GUIDE WIRE WITH A LITTLE MORE FORCE, THE METAL GUIDE PROCEEDED TO DISINTEGRATE, CUT AND LEAVE A FINE METAL THREAD INSIDE THE CATHETER. IT WAS STATED THAT THE PATIENT WAS REPORTED TO BE DECEASED.

  Patient problems: Insufficient Information

  MAUDE report 11060552 ↗
• MalfunctionDec 22, 2020Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE SECUREMENT WING WAS STILL ATTACHED TO THE SKIN VIA SUTURE AND THE STITCHES WERE STILL HOLDING BUT THE CATHETER WAS DISLODGED FROM THE SECUREMENT WING. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS UTILIZED. STERI PREP WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11056725 ↗
• MalfunctionOct 26, 2020Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, WHEN THE PATIENT¿S HEAD WAS TURNED DURING DIALYSIS TREATMENT, THE SECUREMENT WING WAS STILL ATTACHED TO THE SKIN VIA SUTURE AND THE STICHES WERE STILL HOLDING BUT THE CATHETER WAS DISLODGED FROM THE SECUREMENT WING. IT WAS STATED THAT THE CATHETER WAS NOT MIGRATED FROM THE PATIENT'S BODY. CATHETER WAS NOT USED DESPITE THE ISSUE, INSTEAD, A NEW CATHETER WAS REINSERTED TO COMPLETE THE PROCEDURE. FLUSHING WAS DONE PRIOR TO USE OF THE DEVICE AND HAS NO BLOCKAGE. IT WAS STATED THAT THE RING OF THE SUTURE WING WAS NOT BROKEN AND NO UNNECESSARY MOVEMENTS OR ANYTHING HAPPENED THAT MIGHT HAVE CONTRIBUTED ON THE EVENT. STERI PREP WAS THE CLEANING AGENT USED ON THE DEVICE AND ON THE INSERTION SITE. TEGO WAS UTILIZED. THERE WAS NO BLOOD LOSS. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE OR DEFECTS NOTED ON THE CATHETER AND NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED ON THE DEVICE PRIOR TO USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738125 ↗
• MalfunctionOct 26, 2020Migration or Expulsion of Device; Product Quality Problem; Migration or Expulsion of Device; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER DISLODGE FROM SUTURE WING. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, STERI PREP WAS USED AS CLEANING AGENT ON THE DEVICE, TEGO WAS UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS ALSO STATED THAT BLOOD TRANSFUSION WAS NOT REQUIRED, NOTHING UNUSUAL OBSERVED ASIDE FROM THE REPORTED ISSUE, THERE WAS NO OTHER DAMAGE/DEFECTS NOTED ON THE CATHETER THAT MIGHT HAVE CONTRIBUTED ON THE EVENT AND THERE WAS NO UNNECESSARY MOVEMENTS THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE SUTURE WING OF THE CATHETER WAS NOT BROKEN AND THE STITCHES STILL HOLD. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10734883 ↗
• MalfunctionSep 21, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, IT WAS STATED THAT THERE WAS A SPLIT NOTED IN THE ARTERIAL END OF THE DOUBLE-LUMEN CENTRAL VENOUS CATHETER. THERE WAS NO ABNORMALITY FOUND IN CATHETERIZATION, AND THE DIALYSIS PROCESS WENT SMOOTHLY. IT WAS REPORTED THAT CONTRACTED DEALERS HAD NO RECORD OF DELIVERING OUR PRODUCTS TO THE HOSPITAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10562861 ↗
• MalfunctionSep 11, 2020Migration or Expulsion of Device; Product Quality Problem; Migration or Expulsion of Device; Product Quality Problem

  ACCORDING TO THE REPORTER, AFTER THE DIALYSIS TREATMENT WAS FINISHED, THE CATHETER DISLODGED FROM THE SUTURE WING AND WAS COMPLETELY REMOVED OUT OF THE PATIENT. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. STERIPREP WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. REINSERTION OF NEW CATHETER WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10523205 ↗
• InjuryJan 23, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING INSERTION, THE GUIDEWIRE WAS FINE BUT THERE WAS A RESISTANCE WHEN WITHDRAWING AND IT BECAME UNCURL. THEY HAD TO WITHDRAW THE GUIDEWIRE WITH THE CATHETER TOO. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT AND CHLORHEXIDINE WAS USED AS CLEANING AGENT FOR THE DEVICE. THEY HAD TO CHANGE THE INSERTION SITE TO INSERT A NEW CATHETER AS MEDICAL INTERVENTION DONE TO THE PATIENT AND TO RESOLVE THE ISSUE. THE TREATMENT WAS PROCEEDED AND COMPLETED. THE GUIDEWIRE WAS ALL INTACT WHEN IT WAS REMOVED AND POST X-RAY WAS DONE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9621390 ↗
• MalfunctionDec 20, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, 3 DAYS POST INSERTION, IT WAS REPORTED THAT THE CATHETER WAS DISLODGED FROM THE SUTURE WING. IT WAS REPORTED THAT THE INNER LAYER (RING) OF THE SUTURE WING FAILED. IT WAS NOTED THAT THE SUTURE WINGS WERE NOT BROKEN, THE STITCHES HELD AND THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND VISUAL INSPECTION STATED THAT DEVICE WAS IN GOOD CONDITION. THEY HAD TO REMOVE THE CATHETER AND SUTURE WING FROM THE PATIENT TO RESOLVE THE ISSUE. THERE WAS NO BLOOD LOSS FROM THE EVENT. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, CHLORHEXIDINE WAS THE CLEANING AGENT USED, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9503559 ↗
• MalfunctionFeb 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS A LEAK ON THE EXTENSION TUBE AT THE JUNCTION OF THE TUBE AND BIFURCATE. THIS WAS NOTICED BEFORE BEING IMPLANTED AND WAS NOT USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7237989 ↗

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-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-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-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-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