MAHURKAR Elite 8888222220Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521125841), received between Apr 2, 2019 and May 11, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K120674); 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.

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.

• MalfunctionMay 11, 2026Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DISTRIBUTOR REPORTS THAT THEIR CLIENT WAS HAVING TROUBLE WITH THE GUIDE WIRE BENDING WITH DIFFICULTY, THE GUIDEWIRE BECAME STUCK IN THE LUMEN. THE GUIDEWIRE WAS STILL INTACT. NOTHING¿UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. BESIDES THE REPORTED ISSUE, THERE WERE NO VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO REMEDIAL ACTION WITH THE REPORTED PRODUCT, HOWEVER THE PROCEDURE WAS COMPLETED USING GUIDEWIRE FROM A DIFFERENT BRAND OF CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 25142209 ↗
• InjuryDec 12, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AFTER INSERTING THE NEEDLE INTO THE VEIN AND INSERTING THE GUIDE WIRE, THE NEEDLE GOT STUCK IN THE GUIDE WIRE AND WAS NOT REMOVED. BOTH TWO KITS HAD THE SAME ISSUE AND WERE USED ON THE SAME PATIENT. BOTH KITS WERE OBSERVED DURING THE SAME EVENT. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED. THE GUIDE WIRE WAS NEITHER FRAYED, COILED, NOR UNRAVELED. THE PUNCTURE NEEDLE WAS PROVIDED WITH THE KIT BEING USED. FLUSHING WAS DONE PRIOR TO USE, BUT THE RESULT WAS NOT PROVIDED. THE GUIDE WIRE WAS REMOVED AT THE SAME TIME AS THE NEEDLE, AND IT REMAINED INTACT WHEN REMOVED. THE KIT WAS REPLACED. THE PROCEDURE WAS COMPLETED. THERE WAS BLOOD LOSS, BUT NO INFORMATION ON THE AMOUNT OF BLOOD LOST WAS PROVIDED, AND A BLOOD TRANSFUSION WAS REQUIRED. MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT.

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

  MAUDE report 23796730 ↗
• InjuryDec 12, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AFTER INSERTING THE NEEDLE INTO THE VEIN AND INSERTING THE GUIDE WIRE, THE NEEDLE GOT STUCK IN THE GUIDE WIRE AND WAS NOT REMOVED. THIS WAS OBSERVED IN BOTH OF THE TWO (2) KITS. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 23796729 ↗
• MalfunctionJul 25, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THERE WAS CASE OF HD (HEMODIALYSIS) CATHETER MALFUNCTION WHERE THE CATHETER WAS DEFECTIVE COMING OUT OF THE PACKAGING. IT WAS PICKED UP WHEN THEY ATTEMPTED TO DO DIALYSIS AND AIR BUBBLES WERE NOTED IN THE TUBING. IT WAS STATED THAT THERE WAS A DEFECT SEEN AT THE INTERFACE BETWEEN THE BROWN PORT AND THE CATHETER ITSELF ALLOWING THE AIR TO ENTER THE TUBING. THE CATHETER WAS CHANGED. THE CATHETER WAS DISPOSED SO THE CUSTOMER WAS UNSURE OF THE LOT NUMBER. THE PATIENT WAS NOT HARMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392051 ↗
• MalfunctionApr 28, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE CATHETER HAD A HIGHER RATE OF FLOW PROBLEMS EVEN AFTER IMPLANTATION ON THE SAME DAY, THE FLOW DECREASED, IMPAIRING THE QUALITY OF HEMODIALYSIS. THE OCCLUSION OCCURRED AT THE SHAFT OR TIP OF THE CATHETER COMPROMISING THE TIP AND ALSO THE EXIT THROUGH THE SIDE. BEFORE IMPLANTING, THE DOCTOR PERFORMED THE TEST ON THE SYRINGE, IT WAS EVIDENCED IN SOME UNITS THAT THERE WAS A "CERTAIN" RESISTANCE. IT WAS ALSO STATED THAT THERE WAS AN ABSENCE OF IMPROVEMENT WITH WASHING/FLUSHING. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. SALINE SOLUTION WAS THE CLEANING AGENT USED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT THE PRODUCT WAS APPARENTLY INTACT BEFORE INSERTED INTO THE PATIENT. THEY ALWAYS PERFORMED A TEST WITH SS (SALINE SOLUTION) TO CHECK THE FLOW. INITIALLY, THE CATHETER WAS CLOSED ONLY WITH SS. WHEN PROBLEM PRESENTED, IT WAS CLOSED WITH A SOLUTION CONTAINING HEPARIN AND LATER PURE HEPARIN (25,000/5ML). THE CLOSING VALVE OR TEGO WAS USED ROUTINELY AND IT WAS THE OTHER PRODUCT UTILIZED WITH THE DEVICE. LINES WERE ALWAYS INVERTED TO GUARANTEE A DIALYSIS. THE CATHETER WAS REMOVED (DUE TO LACK OF FLOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832810 ↗
• InjuryFeb 14, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING USE FOR ARTERIAL ACCESS FOR DIALYSIS, PATIENT WAS NOTED TO BE BLEEDING FROM THE SITE OF THE DIALYSIS CATHETER. MULTIPLE INTERVENTIONS FAILED TO STOP THE BLEEDING, IT WAS STATED THAT PRESSURE WAS HELD FOR 30 MINUTES, THROMBIN WAS SPRAYED TO THE AREA, AN UNSPECIFIED AMOUNT OF BLOOD WAS LOST AND TRANSFUSION WAS DONE. UPON REMOVAL OF THE CATHETER, IT WAS NOTED TO BE BROKEN AND HAD LINEAR 1 CENTIMETER TEAR JUST ABOVE THE TIP. IT WAS NOT KNOWN WHEN IN THE PROCESS THE CATHETER BROKE AND THE CATHETER HAS ONLY BEEN IN PLACE LESS THAN 24 HOURS. IT WAS REPORTED THAT CHLORHEXIDINE/ALCOHOL APPLICATOR WAS THE CLEANING AGENT USED AND A GLUCONATE DISK WAS USED ON THE EXIT SITE, SORBAVIEW SHIELD WAS THE DRESSING UTILIZED. IT WAS ALSO STATED THAT WOUND DRESSING DID NOT INCLUDE ANY ANTIMICROBIAL PROPERTIES, AND THEY ARE ALLOWED TO DRY THOROUGHLY PRIOT TO DRESSING THE AREA. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE AND THE CLEANING AGENTS WAS NOT SWITCHED OVER THE LIFE OF THE CATHETER, SEPSIDERM WAS NOT USED AND NO PROTOCOL CHANGES WAS USED IN CLEANING THE DEVICE. THE CATHETER WAS THEN REMOVED AND REPLACED.

  Patient problems: Blood Loss

  MAUDE report 9714836 ↗
• MalfunctionApr 2, 2019Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, THE CATHETER'S RED LINE (ARTERIAL) WAS DIFFICULT TO FLUSH/ASPIRATE THAN THAT OF THE BLUE LINE (VENOUS), WHEREIN THE ARTERIAL LINE WAS NOT PATENT/NOT FLOWING SMOOTHLY. IT WAS STATED THAT THE CATHETER WAS REPAIRED, THERE WAS NO LUER ADAPTER ISSUE AND THE CLEANING AGENT USED WAS SODIUM CHLORIDE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8476185 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120674. One submission often covers many models, so check the product and lot details in each record.

• Z-2319-2026 · Apr 29, 2026 · Open, Classified
  Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen
• Z-1007-2018 · Oct 14, 2017 · Terminated
  MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.