MAHURKAR 8888135161Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10884521006355), received between Dec 6, 2017 and Jul 3, 2025 — classified as 2 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (15 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, IT WAS FOUND THAT THE CATHETER'S VENOUS END CONNECTOR WAS BLEEDING. IT WAS STATED THAT THERE WAS A LEAK AT THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NORMAL RESULTS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO ISSUE WITH THE AND NO CRACK WAS OBSERVED AT THE LUER ADAPTER. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER NEEDED TO BE REPLACED. AS A REMEDIAL ACTION, THE CATHETER WAS REPLACED. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A R ESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401501 ↗
• MalfunctionMay 28, 2025Break; Break

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, IT WAS FOUND THAT THE CATHETER HAD BLEEDING (LEAK) AT THE ARTERIAL (RED) LUER ADAPTER. THERE WAS NO CRACK OBSERVED AT THE LUER ADAPTER. 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 DONE WITH NORMAL RESULTS. THE CATHETER WAS NOT REPAIRED, AND TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. BY HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE ADAPTER ISSUE. THE CATHETER WAS REPLACED WITH A NEW SET OF CATHETERS AS A REMEDIAL ACTION, AND INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THE CATHETER HAD BEEN IN PLACE FOR 1 WEEK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094098 ↗
• MalfunctionApr 21, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING NORMAL USE, A WIRE DISPERSION WAS OBSERVED. THERE WAS NO LEAK. NORMAL SALINE WAS USED AS THE CLEANING AGENT ON THE DEVICE. A TEGO WAS NOT UTILIZED, AND THERE WAS NO ISSUE WITH THE LUER ADAPTER. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT BY WIPING WITH BETADINE. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872908 ↗
• MalfunctionAug 6, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT UNDERWENT HEMODIALYSIS TREATMENT IN THE HEMODIALYSIS ROOM. WHEN USING THE CENTRAL VENOUS CATHETER, IT WAS FOUND THAT THE FIXED WING AT THE SUTURE WAS BROKEN. THE SIDE WING PART OF THE WING FAILED, AND THE SUTURE WING WAS DETACHED, BUT THE STITCHES HELD. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. IODINE WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONE PRIOR TO USE AND WITH A NORMAL RESULT. THE SHEATH/CATHETER THAT CAME WITH THE KIT WAS THE ONE USED. THE DIALYSIS MACHINE WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. REMOVED THE CATHETER DIRECTLY WAS THE INTERVENTION/TREATMENT AND THE REMEDIAL ACTION REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED. THE BLOOD WAS SAFELY RETURNED TO THE PATIENT. THERE WAS NO BLOOD LOSS AT THE TIME OF THE EVENT, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. THE DEVICE WAS USED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 19922216 ↗
• MalfunctionJul 12, 2024Break; Break

  ACCORDING TO THE REPORTER, THE CAP BROKE OFF FROM THE PIECE THAT SITS INSIDE THE CATHETER AT INSERTION. IT BROKE BEFORE PLACING IN TO THE PATIENT. LUCKILY, IT WOULD NOT HAVE BEEN ABLE TO GET THAT LONG PLASTIC PIECE OUT OF THE CATHETER, FORCING US TO REMOVE THE CATHETER AND PLACE A NEW ONE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19732008 ↗
• MalfunctionApr 16, 2024Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE GUIDE WIRE DID NOT PASS THROUGH THE INTRODUCER NEEDLE, NEEDLE PRESENTED RESISTANCE. IT WAS ALSO NOTED THAT GUIDE WIRE COULD NOT BE REMOVED FROM THE NEEDLE. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 19116725 ↗
• MalfunctionSep 28, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING CENTRAL VENOUS CATHETER IMPLANTATION, THE CATHETER'S EXTENSION SILICONE TUBE (BLUE SIDE) NEAR THE LUER ADAPTER (LOWER END) WAS NOTED TO HAVE A LEAK DUE TO PRODUCT QUALITY ISSUES. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE PRIOR TO USE WITH A NORMAL RESULT. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. A ROUTINE DISINFECTION WITH A STERILE SALINE CLEANING AGENT WAS USED ON THE DEVICE, AND POVIDONE-IODINE AQUEOUS SOLUTION WAS TYPICALLY USED TO CLEAN THE ADAPTERS. THE INSERTION SITE WAS TREATED WITH POVIDONE-IODINE AQUEOUS SOLUTION PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. TO RESOLVE THE ISSUE, THE PRODUCT WAS REPLACED BY A NEW DEVICE ON THE SAME DAY OF THE EVENT. THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS DUE TO THE EVENT. THERE WAS NO INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839571 ↗
• MalfunctionJun 21, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE BLUE PORT ON VASCATH TUBING HAD A SMALL PIN HOLE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17171175 ↗
• MalfunctionMar 7, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE OPERATION, IT WAS FOUND THAT THE GUIDE WIRE WAS STUCK IN THE PUNCTURE NEEDLE AND COULD NOT BE REMOVED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK OR LUER-ADAPTER ISSUE. TEGO WAS NOT UTILIZED. NO CLEANING AGENT WAS USED ON THE DEVICE OR ON THE INSERTION SITE. THERE WAS NO ABNORMALITY OR NOTHING UNUSUAL WAS OBSERVED PRIOR TO THE USE OF THE DEVICE. FLUSHING WAS PERFORMED PRIOR TO USE AND HAD A NORMAL OUTCOME. THE REPLACEMENT PRODUCT RESOLVED THE ISSUE, AND THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. SIZING (DIMENSION) ISSUES WERE NOT OBSERVED, AND THE GUIDE WIRE PROVIDED WITH THE KIT WAS USED. THE GUIDEWIRE WAS REMOVED TOGETHER WITH PUNCTURE NEEDLE AND TRIED TO BE MOVED OUT OR REMOVED BY HAND WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE. THE GUIDEWIRE WAS INTACT (NOT BROKEN) AND COMPLETE AT THE TIME OF REMOVAL, AND A POST-OPERATIVE X-RAY HAD BEEN PERFORMED TO CHECK THAT ALL PARTS WERE COUNTED. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT AND NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO RESISTANCE NOTICED, AND NO EXCESSIVE FORCE WAS USED ON THE DEVICE THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSIONS WERE NOT NEEDED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500312 ↗
• MalfunctionFeb 23, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHEN PREPARING FOR THE OPERATION, IT WAS FOUND THAT THE SIDE OF THE CATHETER WAS BLOCKED OR OCCLUDED DURING PRE-FLUSHING (THE CUSTOMER STATED OR SUSPECTED THAT THE CATHETER'S TUBE BODY WAS OCCLUDED). THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND THERE WAS NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CATHETER WAS NOT REPAIRED, TEGO WAS UTILIZED, THERE WAS NO LUER ADAPTER ISSUE, THERE WAS NO LEAK, 84 DISINFECTANT WAS USED AS THE CLEANING AGENT ON THE DEVICE AND THE CATHETER THAT CAME WITH THE KIT WAS THE ONE USED. THE CUSTOMER TRY TO REVERSE THE LINES. THEY REPLACED IT WITH A NEW TEMPORARY CATHETER, AND THE OPERATION HAS BEEN COMPLETED AND THE PROGNOSIS WAS GOOD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430068 ↗
• MalfunctionSep 30, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PLACEMENT OF THE CATHETER, THE GUIDEWIRE REMAINS BLOCKED IN THE NEEDLE AND IT WAS IMPOSSIBLE TO PUSH OR WITHDRAW IT. THE NEEDLE AND GUIDEWIRE WAS REMOVED TOGETHER IN THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15513714 ↗
• MalfunctionSep 8, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING INSERTION, THE GUIDEWIRE COULD NOT BE IMPLANTED AND PASSED THROUGH THE PUNCTURE NEEDLE TIP AFTER SUCCESSFUL NEEDLE INSERTION. THE GUIDE WIRE WAS STUCK. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED, NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO TOOLS USED TO REMOVE THE GUIDE WIRE. NO EXCESSIVE FORCE REQUIRED TO REMOVE THE GUIDE WIRE. THE GUIDE WIRE WAS NOT FRAYED/COILED/UNRAVELED. THE GUIDE WIRE WAS STILL INTACT. NO RESISTANCE NOTED WHEN INSERTING THE GUIDE WIRE. 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. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS NORMAL. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE GUIDE WIRE AND NEEDLE WERE WITHDRAWN TOGETHER. IMPLANTATION WAS SUCCESSFUL AFTER REPLACEMENT OF PACKAGE WITH THE SAME PRODUCT ID (IDENTIFIER) AND BATCH NUMBER ON THE SAME DAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382325 ↗
• MalfunctionJul 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE INSTALLATION OF THE CATHETER, WHEN THEY INJECTED THE SALINE SOLUTION, THE LUMEN WAS KEPT ON THE HAND OF THE DOCTOR. THE VENOUS EXTENSION TUBE WAS DETACHED FROM THE BIFURCATE AND HAD LEAKAGE. WHEN THIS WAS EVIDENT, ANOTHER DEVICE WAS SOUGHT AND REPORTED. THE PROCEDURE WAS COMPLETED AND THE CATHETER WAS REPLACED THE SAME DAY. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND THERE WERE NO OTHER DEFECT/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WAS NO AIR EMBOLISM HAPPENED TO THE PATIENT, THE BLUE EXTENSION TUBE WAS NOT PULLED AND THERE WAS NO EXCESSIVE FORCE USED TO PULL IT OR THE PRODUCT. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE JUNCTION OF EXTENSION TUBE AND BIFURCATE, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATION ASSOCIATED WITH THIS EVENT, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982168 ↗
• MalfunctionMay 18, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ONE DAY AFTER THE CATHETER INSTALLATION, A RUPTURE WAS OBSERVED WHERE THE CLAMP FORCEPS WAS. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE EXTENSION TUBE, POVIDONA INSERTION SITE WAS USED AS THE CLEANING AGENT USED ON THE DEVICE, THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE TREATMENT WAS DELAYED AND THE PATIENT'S CATHETER WAS REPLACED WITH A NEW ONE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432057 ↗
• MalfunctionMar 28, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, IT WAS NOTED THAT THERE WAS A LEAKAGE AT THE JUNCTION OF THE VENOUS EXTENSION TUBE AND LUER ADAPTER. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE COMPLICATION OR OTHER EFFECT ON PATIENT RESULTING FROM THIS EVENT WERE RE-IMPLANTATION AFTER EXTUBATION AND VASCULAR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 13930200 ↗
• MalfunctionOct 19, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AFTER THE PUNCTURE NEEDLE WAS WITHDRAWN, WHEN INSERTING THE CATHETER THROUGH THE GUIDE WIRE, THE CATHETER WAS NOT SMOOTHLY INSERTED. WHEN THE GUIDE WIRE WAS WITHDRAWN, IT HAD BENT (IMMEDIATELY BEFORE THE J-SHAPE), IT WAS ALSO STUCK/NOT PASSING THROUGH THE CATHETER AND IT WAS NECESSARY TO REMOVE THE GUIDE WIRE TOGETHER WITH THE CATHETER, AFTER TAKING IT OUT TOGETHER, THEY REMOVED THE GUIDE WIRE FROM THE CATHETER. THE PRODUCT WAS REPLACED WITH THE SAME LOT ON THE SAME DAY OF THE EVENT, THE NEW CATHETER/REPLACEMENT KIT WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. IT WAS MENTIONED THAT THE BENT/ISSUE WITH THE GUIDE WIRE WAS NOT NOTICED IN THE PACKAGING. NO TOOLS USED WHEN TRYING TO REMOVE THE GUIDEWIRE. THE GUIDE WIRE WAS NOT FRAYED, COILED, UNRAVELED AND WAS STILL INTACT (IN ONE PIECE). NO RESISTANCE ENCOUNTERED WHEN INSERTING OR WITHDRAWING THE GUIDEWIRE. NO EXCESSIVE FORCE REQUIRED WHEN INSERTING THE GUIDE WIRE. THE GUIDE WIRE AND THE NEEDLE USED WERE THE ONES INCLUDED IN THE KIT. THE DIMENSIONS OF THE CATHETER/PUNCTURE NEEDLE HAD MATCHED WHAT WAS INDICATED ON THE LABEL. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657983 ↗
• MalfunctionSep 15, 2021Migration or Expulsion of Device; Product Quality Problem; Migration or Expulsion of Device; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING USE, IT WAS NOTED THAT THE CATHETER SUTURE WINGS WAS DETACHED (PROLAPSED). THE RING OF THE SUTURE WING FAILED BUT NOT DAMAGED (BROKEN) AND THE STITCHES HELD. THE CATHETER MOVED OUT OF PLACE DUE TO SECUREMENT WING ISSUE AND IT WAS SECURED WITH TAPE TO MAINTAINED IN PLACE. THE DEVICE WAS NOT USED SUCCESSFULLY. THE DEVICE WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH IODOPHOR DISINFECTION PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM DETACHMENT OF SUTURE WINGS. THERE WERE NO UNNECESSARY MOVEMENTS AND NO OTHER FACTOR/S SUCH AS CLOTHING THAT MIGHT CONTRIBUTED TO THE EVENT. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED. IT WAS ALSO STATED THAT SINCE THE OLD WING HAS FAILED, THE DEVICE WAS REPLACED AND A NEW CATHETER WAS USED TO RESOLVE THE ISSUE AND AS THE MEDICAL INTERVENTION/TREATMENT DONE. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12473923 ↗
• MalfunctionSep 8, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PRIOR TO USE, DURING FLUSHING (PRE-FILLING) WITH 0.9% SODIUM CHLORIDE, LIQUID LEAKAGE WAS NOTED IN THE EXTENSION TUBE NEAR THE BLUE LUER CONNECTOR. A HOLE WAS FOUND WHERE THE LEAK WAS OBSERVED. THERE WAS NO PACKAGE DAMAGE. THE BOX THAT THE DEVICE CAME IN AND THE STERILE BARRIER WERE INTACT. THE CATHETER WAS NOT REPAIRED. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER CONNECTOR ISSUE. IODOPHOR DISINFECTION WAS DONE ON THE INSERTION SITE (SKIN) PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENTS WERE NOT ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE CLAMP WAS NOT MOVED PERIODICALLY. NO METHOD INVOLVED/UTILIZED TO TIGHTEN THE ADAPTERS. NO CLEANING AGENT INVOLVED/UTILIZED TO CLEAN THE ADAPTERS. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION/TREATMENT PROVIDED DUE TO THE EVENT. TO RESOLVE THE ISSUE, THE PRODUCT WAS REPLACED WITH ANOTHER SET (THEY PULLED OUT ANOTHER ONE WITH THE SAME LOT) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443682 ↗
• MalfunctionAug 17, 2021Product Quality Problem; Component Missing; Product Quality Problem; Component Missing

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED ON (B)(6) 2021. WHEN IT WAS USED THE NEXT DAY, IT WAS FOUND THAT THE ARTERIAL AND VENOUS ENDS WERE INTEROPERABLE. BLOOD ENTERED FROM BOTH MOUTHS AT THE SAME TIME AND HEMODIALYSIS TREATMENT COULD NOT BE PERFORMED NORMALLY. IT WAS MENTIONED IT WAS NOT LEAKING AT THE JUNCTION OF THE BIFURCATE AND CATHETER. AFTER DISCOVERING THE CATHETER HAD AN ISSUE, THE CATHETER WAS PULLED OUT, CAUSING 10ML OF BLEEDING/BLOOD LOSS. THEY HAD TO EXTUBATE AND RE-IMPLANT WITH A NEW CATHETERON THE SAME DAY OF THE EVENT. AFTER REPLACEMENT, THE DIALYSIS TREATMENT WAS COMPLETED. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE AND UTILIZED TO CLEAN THE CATHETER IN ITS ENTIRETY. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO SOLUTION/AGENT USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS DONE WHICH HAD A NORMAL RESULT (NO ABNORMALITY). THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE AND NO OTHER D EFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO OINTMENT UTILIZED (DID NOT APPLY) AT THE EXIT SITE AND PACKAGING CONVENTIONAL DRESSINGS WERE UTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331138 ↗
• MalfunctionJul 28, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS IMPLANTED INTO THE PATIENT¿S FEMORAL VEIN AND THE MACHINE WAS USED FOR PROCEDURE, IT WAS FOUND THAT THE CONNECTION BETWEEN THE VENOUS END EXTENSION TUBE AND THE JOINT HAD A CRACK AND BLEEDING. THE DOCTOR AGAIN GAVE THE PATIENT A CENTRAL VENOUS CATHETERIZATION OPERATION. THE CATHETER WAS NOT REPAIRED, NO TEGO UTILIZED AND NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE PATIENT'S SECONDARY INTUBATION DELAYED THE TREATMENT TIME, CAUSED SECONDARY TRAUMA TO THE BODY, AND PSYCHOLOGICAL EFFECTS. THE PATIENT OUTCOME WAS ALIVE WITH INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12239073 ↗
• MalfunctionJul 7, 2021Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, DUE TO UREMIA AND ACUTE HEART FAILURE, THE PATIENT UNDERWENT TO EMERGENCY HEMODIALYSIS TREATMENT AT 16:30. IN THE WARD, THE PATIENT WAS GIVEN A TEMPORARY HEMODIALYSIS CATHETER IN THE RIGHT FEMORAL VEIN. THE RIGHT FEMORAL VEIN WAS PUNCTURED SMOOTHLY WITH A THICK NEEDLE AND THE GUIDE WIRE WAS GUIDED INTO THE THICK NEEDLE. THE GUIDE WIRE TIP WAS EMBEDDED IN THE PUNCTURE NEEDLE, AND THE GUIDE WIRE COULD NOT GET IN OR OUT. AFTER PULLING OUT THE GUIDE WIRE FORCEFULLY, IT WAS FOUND THAT THE GUIDE WIRE TIP HAD BEEN ELONGATED AND DAMAGED, AND THE GUIDE COULD NOT BE COMPLETED. LATER, THEY REPLACED THE GUIDE WIRE OF THE SAME BATCH WITH A NEW PACKAGE OF HEMODIALYSIS CENTRAL VENOUS CATHETER KIT, WHICH WAS SUCCESSFULLY COMPLETED. IT WAS ALSO MENTIONED THAT IODOPHOR WAS USED AS THE SOLUTION OR CLEANING AGENT ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS PERFORMED WITH NO PROBLEM RESULT AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE DEVICE, THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION AND THERE WAS NO OCCLUSION. THE GUIDE WIRE TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129329 ↗
• MalfunctionJun 3, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS INSERTED, THE GUIDE WIRE TIP DID NOT PASS THROUGH THE PUNCTURE NEEDLE TIP, IT WAS STUCK IN THE PUNCTURE NEEDLE AND COULD NOT BE WITHDRAWN. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. IODOPHOR WAS THE CLEANING AGENT USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS DONE WHICH HAD A NORMAL RESULT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT AND THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION. THERE WAS NO OCCLUSION AND THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THE GUIDE WIRE WAS NOT REMOVED (STAYED STUCK IN THE NEEDLE) AND THERE WERE NO TOOLS USED WHEN TRYING TO REMOVE THE GUIDE WIRE. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. WHEN THE GUIDE WIRE WAS REMOVED, IT WAS STILL INTACT. THERE WAS NO BLOOD LOSS AND NO INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935806 ↗
• MalfunctionMar 11, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, IT WAS SAID THAT THE PUNCTURE NEEDLE WAS PUNCTURED INTO THE VEIN AND THE BLOOD WAS DRAWN BACK. WHEN THE GUIDE WIRE WAS INSERTED, THE GUIDE WIRE TIP COULD NOT PASS THROUGH THE PUNCTURE NEEDLE TIP, AND WAS STUCK IN THE PUNCTURE NEEDLE (WITHOUT BREAKING) AND COULD NOT BE WITHDRAWN, SO IT EXITED THE BLOOD VESSEL TOGETHER WITH THE PUNCTURE NEEDLE. THE PRODUCT WAS NOT USED AND WAS REPLACED TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED. NOTHING UNUSUAL OBSERVED PRIOR TO USE. NO PACKAGE DAMAGE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO RESISTANCE DURING INSERTION OF THE GUIDEWIRE TO THE NEEDLE. NO EXCESSIVE FORCE APPLIED. NORMAL SALINE FLUSHING WAS DONE PRIOR TO USE AND NO OCCLUSION NOTED. THE DIMENSION OF THE NEEDLE AND GUIDEWIRE MATCHED WITH THE PACKAGE LABEL. THE NEEDLE AND GUIDEWIRE WERE PART OF THE KIT BEING USED. ALL PIECES OF THE GUIDEWIRE WERE ACCOUNTED FOR (NO BROKEN PIECES). THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH IODOPHOR DISINFECTION PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO XRAY DO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467998 ↗
• MalfunctionJan 14, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE OPERATION, AFTER THE PUNCTURE NEEDLE ENTERED ALONG WITH THE GUIDEWIRE, THE GUIDE WIRE GOT STUCK AT THE NEEDLE WHEN IT WAS ABOUT TO BE PULLED AND IT COULD NOT BE WITHDRAWN. AFTER THE GUIDEWIRE AND THE PUNCTURE NEEDLE WERE WITHDRAWN TOGETHER, THE GUIDE WIRE WAS FOUND TO BE SIGNIFICANTLY BENT AND THE GUIDEWIRE COULD NOT BE WITHDRAWN SMOOTHLY. THE CATHETER WAS NO REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, THERE WAS NO CLEANING AGENT USED ON THE DEVICE, THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO THE EVENT. THEY REPLACED WITH A NEW CATHETER TO RESOLVE THE ISSUE, THE PROCEDURE WAS PROCEEDED AND COMPLETED. RE-PUNCTURE OR RE-CATHETERIZATION WAS PERFORMED AS THE INTERVENTION/TREATMENT REQUIRED AS THE RESULT OF THE ISSUE, NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS PERFORMED WITH NORMAL RESULT, THERE WAS NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, THE GUIDEWIRE THAT WAS USED WAS THE ONE INCLUDED IN THE KIT AND THERE WAS NO DAMAGE/DEFECT TO THE CATHETER ITSELF. THERE WAS NO DAMAGE TO THE EXTERNAL PACKAGING AND BOX. IODOPHOR WAS USED TO TREAT THE INSERTION SITE PRIOR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11172693 ↗
• MalfunctionDec 21, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN ESTABLISHING HEMODIALYSIS ACCESS, THE TEMPORARY CENTRAL VENOUS CATHETER GUIDE WIRE STUCK IN THE NEEDLE AND COULD NOT BE PULLED OUT. IT WAS STATED THAT DEEP VEIN CATHETERIZATION COULD NOT BE PERFORMED. THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11045160 ↗

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-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-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-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-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-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