MAHURKAR 8888135133Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521006256), received between Jun 6, 2017 and Sep 8, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Break; Device Markings/Labelling Problem; Break; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, BEFORE USE ON THE PATIENT, DURING PERMEABILITY TESTING, THE EXPIRY DATE AND LOT INFORMATION WERE NOT LEGI BLE, AND THEREFORE IT CANNOT BE DISPENSED TO THE SERVICE. THE REMEDIAL ACTION PERFORMED WAS TO REPLACE THE PRODUCT. THE UNUSUAL THING OBSERVED ON THE DEVICE WAS A CRACK AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998827 ↗
• MalfunctionMar 25, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS INSERTED THROUGH THE NEEDLE (INTRAOPERATIVE), THE GUIDEWIRE BECAME STUCK IN THE NEEDLE AND COULD NOT BE REMOVED INDEPENDENTLY. NO TOOLS WERE USED TO REMOVE THE GUIDE, AND NO EXCESSIVE FORCE WAS APPLIED. THE GUIDE CAME FROM THE NOTIFIED KIT. THERE WAS NOTHING UNUSUAL OBSERVED IN THE DEVICE BEFORE USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND IN THE PRODUCT. NO OTHER PRODUCTS IN THE KIT WERE USED. THE PUNCTURE NEEDLE DID NOT PRESENT ANY VISIBLE DAMAGE OR DIMENSION ISSUES. THE CATHETER WAS CORRECTLY FLUSHED PRIOR TO USE, AND THE PUNCTURE NEEDLE BELONGED TO THE CATHETER KIT PROVIDED BY THE COMPANY. NO CLEANING AGENTS WERE USED. NO OTHER GUIDEWIRE WAS USED, AND THE CLINICIAN HAD TO REMOVE THE GUIDEWIRE ALONG WITH THE PUNCTURE NEEDLE. A NEW CATHETER OF THE SAME BRAND AND REFERENCE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY ON THE SAME DAY. THERE WAS NO BLOOD LOSS. AN X-RAY WAS NOT TAKEN AFTER THE PROCEDURE. NO MEDICAL INTERVENTION OR TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 21687454 ↗
• InjuryMar 13, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING PLACEMENT OF A HIGH-FLOW CATHETER IN THE RIGHT JUGULAR VEIN, AN EVENT RELATED TO THE METAL GUIDE OCCURRED. WHEN PASSING THE GUIDE THROUGH THE NEEDLE, IT WAS NOT POSSIBLE TO ADVANCE OR WITHDRAW IT, AND WHEN REMOVING THE NEEDLE AND THE CATHETER FROM THE VESSEL, A FRAYED METAL GUIDE WAS SEEN THAT DID NOT COME OUT OF THE NEEDLE (IT COULD NOT BE REMOVED FROM THE NEEDLE). THE INTENSIVE CARE UNIT WAS EQUIPPED WITH A TE7 MINDRAY ULTRASOUND MACHINE, WHICH WAS USED FOR THE PLACEMENT OF ALL VASCULAR ACCESS AND ALSO FOR PERFORMING ULTRASOUNDS SUCH AS POCUS (POINT-OF-CARE ULTRASOUND). AN ULTRASOUND SCAN OF THE COMPROMISED VESSEL WAS SUBSEQUENTLY PERFORMED, AND THE PRESENCE OF A HEMATOMA WAS EVIDENT. AT THE TIME OF THE EVENT DURING THE PROCEDURE, THE PHYSICIAN REMOVES THE CATHETER TOGETHER WITH THE NEEDLE AND RE-RUNS THE SWEEP ULTRASOUND TO ASSESS THE INTEGRITY OF THE VESSEL WITH A HEMATOMA. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT PERFORMED SINCE IT DID NOT APPLY TO STERILE DEVICES. THERE WAS NO CLEANING AGENT SINCE IT DID NOT APPLY TO STERILE DEVICES. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE GUIDEWIRE DID NOT

  Patient problems: Hematoma

  MAUDE report 21596436 ↗
• MalfunctionMar 3, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE ULTRASOUND-GUIDED VESSEL CANALIZATION PROCEDURE, THE GUIDE WAS FRAYED, BUT IT DID NOT BREAK INTO PIECES. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO TOOLS WERE USED TO REMOVE THE GUIDE WIRE. NO EXCESSIVE FORCE WAS APPLIED TO THE PRODUCT. THE GUIDE WIRE CAME FROM THE REPORTED KIT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. THE CLINICIAN REMOVED THE GUIDE WIRE ALONG WITH THE NEEDLE BECAUSE THE GUIDE WIRE DID NOT MOVE OR EXIT THE NEEDLE AND ORDERED A NEW CATHETER KIT. THE ISSUE WAS ADDRESSED BY REPLACING IT WITH A NEW GUIDE WIRE, WHICH DID NOT CAUSE ANY INCONVENIENCE, AND IT ADVANCED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 21503199 ↗
• MalfunctionAug 18, 2023Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, RIGHT JUGULAR VEIN PUNCTURE WAS PERFORMED BY A NEPHROLOGIST, AND AT THE TIME OF GUIDEWIRE INSERTION INTO THE TRUCUT NEEDLE, THE GUIDEWIRE DID NOT ADVANCE IN THE EXIT PORT, PATENCY WAS VERIFIED, AND THE LUMEN OR HOLE OF THE NEEDLE WAS SMALLER THAN THE GUIDEWIRE DIAMETER. APPARENTLY, THE NEEDLE WAS THE ONE ON THE LABEL; THE DIMENSIONS OF THE NEEDLE MATCHED WHAT WAS INDICATED ON THE LABEL, BUT IT WAS DEFECTIVE. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AT THE SAME TIME AS THE PUNCTURE NEEDLE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE PUNCTURE NEEDLE USED WAS THE ONE INCLUDED IN THE KIT. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED WITH THE NEEDLE. THE GUIDE WIRE WAS NOT FRAYED, COILED, OR UNRAVELED. THE GUIDE WIRE DID NOT BREAK INTO PIECES. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. NO OTHER PRODUCTS WERE BEING USED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT HAD NO PROBLEM. NO CLEANING AGENT WAS USED ON THE DEVICE. A NEED TO OPEN A NEW CATHETER FROM THE SAME PRODUCT ID (IDENTIFIER) AND SAME LOT WAS GENERATED, AND T HE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17579435 ↗
• MalfunctionSep 28, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, IN THE MOMENT OF CONNECTION, IT WAS OBSERVED IN LUMENS OF THE BRANCHES OF THE CATHETER THAT THERE WERE FISSURES THAT ALLOW THE PASSAGE OF AIR WHEN RETURNING WITH THE 5 CC SYRINGE. THE DOCTOR WAS INFORMED AND HAD TO OPEN A NEW CATHETER TO CHANGE THE PRODUCT AND CONTINUE WITH THE DIALYSIS THERAPY. THE CATHETER WAS NOT REPAIRED. TEGO WAS UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. 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 PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543589 ↗
• MalfunctionAug 27, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHEN THE DOCTOR WAS ABOUT TO INSERT THE CATHETER, IT WAS STATED THAT WHEN PASSING THE GUIDE THROUGH THE VENOUS LUMEN (AS ESTABLISHED IN THE PROTOCOL), IT WAS NOTED THAT THERE WAS NO PERMEABILITY IN THE CATHETER FOR THE PASSAGE OF THE GUIDE WHICH SHOWED RESISTANCE. THE CATHETER WAS PERMEABILIZED WITH 0.9% SSN, FINDING RESISTANCE TO FLOW. IT WAS SAID THAT THE CATHETER WAS DAMAGED. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. 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 WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377653 ↗
• MalfunctionSep 14, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AT THE MOMENT OF CHANNELING THE VEIN AND PASSING THE GUIDE IT WAS EVIDENT/NOTED THAT IT WAS NOT ADVANCING. GUIDE WIRE, NEEDLE AND CATHETER WERE REMOVED SIMULTANEOUSLY. IT WAS REPORTED THAT THE GUIDEWIRE WAS NORMAL BUT IT WAS STUCK IN THE NEEDLE PREVENTING IT TO ADVANCE OR TO REMOVE, SO IT WAS NECESSARY TO REMOVE THE GUIDE AND NEEDLE AT THE SAME TIME. EXCESSIVE FORCE WAS NOT USED TO REMOVING OR INSERTING THE GUIDEWIRE. IT WAS NOT BROKEN INTO PIECES, THERE'S NOTHING LEFT ON THE BODY OF THE PATIENT. TO CONTINUE THE PROCEDURE IT WAS SAID THAT THEY HAD TO USE THE THIRD FEMORAL CATHETER. THERE WAS NOTHING UNUSUAL OBSERVED PRIOR TO USE. IT WAS REPORTED THAT THE GUIDE WIRE THAT WAS USED WAS THE ONE INCLUDED IN KIT. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE. THE PROCEDURE CANNOT BE COMPLETED WITH THE JUGULAR CATHETER BUT IT WAS COMPLETED WITH FEMORAL CATHETER. CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE RE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529337 ↗
• MalfunctionSep 4, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE GUIDE WIRE REMAINED STUCK AT THE NEEDLE AND HAD DIFFICULTY IN WITHDRAWING IT. IT WAS ALSO MENTIONED THAT IT WAS DAMAGED WHEN PRESSED WHILE WITHDRAWING THE GUIDE WIRE. 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. THE CATHETER WAS REPLACED WITH THE SAME REFERENCE OF CATHETER BUT IT PRESENTS THE SAME PROBLEM. THEY HAD TO REMOVED THE SECOND CATHETER WITH THE GUIDE WIRE AT THE SAME TIME AND USED A THIRD FEMORAL CATHETER TO COMPLETE THE PROCEDURE AND RESOLVE THE ISSUE. NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE USE, THERE WAS NO BLOOD LOSS, BLOOD TRANSFUSION WAS NOT REQUIRED, FLUSHING WAS NOT PERFORMED, THERE WERE OTHER PRODUCTS BEING USED WITH THE DEVICE AND THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. IT WAS ALSO MENTIONED THAT THE GUIDE WIRE GOT STUCK IN THE NEEDLE WHICH PREVENTING IT TO ADVANCE OR TO BE REMOVED. THERE WAS NO EXCESSIVE FORCE USED WHEN INSERTING OR REMOVING THE GUIDE WIRE, THE GUIDE WIRE DID NOT BREAK INTO PIECES, NO PARTS OF THE GUIDE WIRE WAS LEFT IN THE PATIENT'S BODY AND THE GUIDE WI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10492524 ↗
• MalfunctionFeb 12, 2020Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS FOUND TO HAVE A LEAK IN THE CATHETER SHAFT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LUER ADAPTER ISSUE, AND THERE WAS NO LEAK AT THE JUNCTION OF THE BIFURCATE AND CATHETER. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. CHG WAS THE CLEANING AGENT USED ON THE DEVICE. IT WAS ALSO STATED THAT THE CATHETER WAS NOT WORKING PROPERLY WHICH LED TO IMPROPER DIALYSIS TREATMENT AND CATHETER REPLACEMENT. THE CATHETER WAS REPLACED WITH ANOTHER PRODUCT (COMPETITOR'S PRODUCT). THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700723 ↗
• MalfunctionDec 13, 2018Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD AN EXTERNAL BLOOD LEAKAGE (A DROP) AT THE POINT THAT CLAMP CLOSE. IT WAS NOTED THERE WAS A BLOOD LOSS OF LESS THAN 150ML. IT WAS REPORTED THE PRODUCT WAS REPLACED, AND THERE WERE NO OTHER DEFICIENT PRODUCT USED. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160293 ↗
• MalfunctionJun 6, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES DURING HEMODIALYSIS THE MACHINE ALARMED AND A BLOOD LEAKAGE WAS NOTICED DUE TO A RUPTURE IN THE SET. THE THERAPY WAS STOPPED, THE CATHETER CHANGED AND THE PATIENT WAS DISCHARGED NORMALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6614496 ↗

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-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-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-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-0421-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
• Z-1955-2019 · Apr 29, 2019 · Terminated
  MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 88156
• Z-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