MAHURKAR 8888135163Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521006386), received between May 1, 2019 and Apr 11, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS BEING INSTALLED, THE GUIDE WIRE WAS DAMAGED (COILED) AS IT MOVED FORWARD. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING ELSE UNUSUAL OBSERVED ON THE DEVICE. THE PROBLEM WAS ON THE GUIDE WIRE ONLY. THERE WAS NO ISSUE WITH THE CATHETER ITSELF. FLUSHING WAS NOT DONE. THE CATHETER WAS REPLACED ON THE SAME DAY, AND THE NEW ONE WORKED WITHOUT PROBLEMS AND THE PROCEDURE WAS COMPLETED. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. 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 19088172 ↗
• MalfunctionSep 6, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS INSTALLED ON (B)(6) 2023 FOR HEMODIALYSIS, AND AFTER 5 HEMODIALYSIS SESSIONS OF 6 HOURS EACH, IT PRESENTED A FISSURE AND FLUID LEAKAGE ON THE EXTENSION TUBE NEAR THE VENOUS LUER ADAPTER WHEN IT WAS HANDLED ON THE DAY OF THE EVENT. FLUSHING (DISINFECTION) WAS DONE BEFORE USE, AND WHEN THE CATHETER WAS TESTED WITH THE SYRINGE BEFORE STARTING THE PROCEDURE, BLOOD LEAKAGE WAS OBSERVED. THE ISSUE WAS ONLY OBSERVED DURING THE LAST HEMODIALYSIS SESSION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THE CATHETER WAS NOT REPAIRED AND WAS NOT POSSIBLE TO USE. TEGO WAS UTILIZED, AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. CHLORHEXIDINE WAS TYPICALLY USED TO CLEAN THE ADAPTERS AND THE ENTIRE CATHETER. AFTER CLEANING, IT WAS COVERED WITH STERILE GAUZE, AND THERE WAS NO OINTMENT APPLIED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER HAD BEEN IN PLACE FOR SIX DAYS. WHEN THE PROBLEM WAS IDENTIFIED, IT WAS NECESSARY TO REMOVE AND C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695018 ↗
• MalfunctionNov 15, 2021Difficult to Remove; Defective Component; Difficult to Remove; Defective Component

  ACCORDING TO THE REPORTER, AT THE TIME OF REMOVING THE GUIDEWIRE DURING A CATHETER INSERTION PROCEDURE, RESISTANCE WAS ENCOUNTERED. IT WAS SAID THAT THE GUIDEWIRE WAS STUCK AND IT WAS NOT POSSIBLE TO WITHDRAW, SO IT WAS DECIDED TO REMOVE TOGETHER WITH THE CATHETER. THE GUIDEWIRE WAS SAID TO BE NOT BROKEN. WHEN REVIEWING THE INPUT, AN OUTLET HOLE WAS OBSERVED WITH A REDUCED SIZE PREVENTING THE PASSAGE OF THE GUIDEWIRE. THE CATHETER WAS SAID TO BE DAMAGED. IT WAS SAID THAT THE PART OF THE CATHETER WHERE THE JAM OCCURRED WASAT THE DISTAL END, CAUSING WEDGING OF THE METAL GUIDE BUT THERE WAS NO INFORMATION ON WHICH PART OF THE GUIDEWIRE GOT STUCK AND IT WAS NOT REPORTED TO HAVE BEEN FRAYED OR TANGLED. NOTHING UNUSUAL WAS OBSERVED IN THE DEVICE BEFORE USE. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE GUIDEWIRE PROVIDED IN THE KIT WAS USED. IT WAS SAID THAT IT WAS NOT POSSIBLE TO EVALUATE IF THE DIMENSIONS MATCHED WITH WHAT WAS SPECIFIED ON THE LABEL AS THE DEVICE WAS DISCARDED. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT HAD NO REQUIRED INTERVENTION DUE TO THE EVENT. TO SOLVE THE PROBLEM, ANOTHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12810639 ↗
• MalfunctionJun 8, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER INSERTION PROCEDURE BEGAN AND WHEN THE PROCEDURE WAS CARRIED OUT, THE CATHETER'S GUIDE WIRE BECAME ENTANGLED IN THE PUNCTURE NEEDLE. WHEN WITHDRAWING IT, IT WAS OBSERVED THAT THE NEEDLE WAS DEFECTIVE AND DID NOT ALLOW REMOVAL. 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 AND CLEANING ON THE INSERTION SITE WAS PERFORMED WITH SURGICAL SOAP AND SURGICAL SOLUTION PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WAS NO EXCESSIVE FORCE USED TO PULL THE PRODUCT. THE PRODUCT WAS NOT RINSED BEFORE USE AND THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO PROBLEMS WITH THE SIZE OF THE CATHETER AND THERE WAS NO OCCLUSION. THE GUIDE WIRE USED AND PRESENTED THE ISSUE WAS THE ONE INCLUDED IN THE KIT. THEY TRIED TO REMOVE THE GUIDE WIRE FIRST AND WHEN IT WAS EVIDENT THAT THE REMOVAL WAS DIFFICULT, A SLIGHT CONTROL WAS EXERCISED THAT FACILITATED THE EXIT OF THE GUIDE WIRE AND THE SUBSEQUENT REMOVAL OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956986 ↗
• MalfunctionJul 2, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE CATHETER INSERTION PROCEDURE, MATERIAL WITH BLOOD WAS SEEN LEAVING (LEAK) THE ARTERIAL LINE DURING THE SALT SOLUTION INFUSION (FLUSHING). IT WAS STATED THAT AFTER INSERTION, THE LUMEN'S PERMEABILITY WERE TESTED BY PULLING OUT/PUSHING BACK THE BLOOD FROM EACH TO THE EXTENSION TUBES (LUMEN) AND RINSING (FLUSHING) IT AFTERWARDS WITH A 0.9% SALINE SOLUTION. IT WAS REPORTED THAT THERE WAS A LEAK IN THE EXTENSION TUBE. IT WAS DURING THIS PHASE THAT THE EVENT WAS OBSERVED AND THE PHYSICIAN DETERMINED THAT THE DEVICE BE REMOVED. THERE WAS NOTHING UNUSUAL OBSERVED WITH THE PRODUCT PRIOR TO USE, NO DAMAGE WAS NOTED ON THE KIT AND IT WAS STILL SEALED UPON RECEIPT. IT WAS SAID THAT THE 0.9% SALINE SOLUTION WAS USED TO CLEAN THE DEVICE AND THE INSERTION SITE WAS TREATED WITH A DISINFECTANT SOLUTION (SALINE SOLUTION AND DISINFECTION QUIRUCIDAL AN QUIRUGICAL SOAP) WITH FLARE AND SURGICAL FLAP. IT WAS ALSO REPORTED THAT THE PATIENT HAD 20 ML BLOOD LOSS BUT BLOOD TRANSFUSION WAS NOT REQUIRED. THE PRODUCT WAS NOT REPAIRED, AND THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS ALSO REPORTED THAT TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10226249 ↗
• MalfunctionMay 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING PUNCTURING, THERE WAS RETURN OF AIR WHEN THE CATHETER WAS FIRST INSERTED IN THE RIGHT JUGULAR VEIN. THE PROCEDURE WAS STOPPED AND AN ATTEMPT TO DO CATHETER INSERTION IN THE FEMORAL VEIN WAS DONE. AFTER ASEPSIS AND ANTISEPSIS AT THE RIGHT INGUINAL LEVEL UNDER ULTRASOUND GUIDANCE, THERE WAS LOSS OF RESISTANCE AND THE SYRINGE WAS FILLED WITH AIR. THERE WAS LEAKAGE FOUND IN THE PUNCTURE NEEDLE. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPAIRED AND THERE WAS NO ISSUE WITH THE LUER ADAPTER. THE DEVICE WAS REPLACED IN ORDER TO RESOLVE THE ISSUE. THE VESSEL WAS ACCESSED AND THERE WAS NO EVIDENCE OF HEMATOMA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8580912 ↗
• MalfunctionMay 1, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING CONTINUOUS RENAL REPLACEMENT THERAPY, THERE WAS NOTED TO BE A CATHETER TEAR OR RUPTURE. IT WAS STATED THAT THE SOFT PLASTIC TUBING OF THE VENOUS PORT MAY HAVE BEEN SHEARED BY THE CLAMP WHICH RESULTED INTO A LEAK IN THE VENOUS PORT JUST DISTAL TO THE HUB. THE LINE WAS REMOVED AND REPLACED IN ORDER TO COMPLETE THE TREATMENT. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPAIRED AND THERE WAS NO ISSUE WITH THE LUER ADAPTER. THE CLEANING AGENT USED ON THE DEVICE WAS CHG SPONGES. TEGO CAPS WERE UTILIZED UNTIL THE LINE WAS BEGINNING TO HAVE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569694 ↗

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-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-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-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-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