MAHURKAR Elite 8888211216Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521125377), received between Apr 15, 2022 and Oct 4, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ABOUT 2 DAYS OF INSERTION, DURING NORMAL USE, BLOOD WAS LEAKING FROM THE END OF BOTH VENOUS (BLUE SIDE) AND ARTERIAL (RED SIDE) EXTENSION TUBES EVEN IF THE CLAMPS WERE CLOSED. THE CATHETER WAS NOT REPAIRED. THE TYPE OF CLEANING AGENT THAT WAS USED ON THE DEVICE COULD NOT BE SPECIFIED AND NORMAL PROTOCOL OF THE HOSPITAL WAS FOLLOWED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE ADAPTERS WERE NOT CLEANED REGULARLY BUT ONLY IF CONTAMINATED WITH BLOOD. DENATURED ALCOHOL WAS USED FOR CLEANING THE ADAPTERS. THE CLAMP WAS NOT MOVED PERIODICALLY; THEY WERE OPEN IN CONTINUOUS DIALYSIS ALL THE TIME. IF THERE WAS A DIALYSIS SET CHANGE, THEN THE CLAMPS WERE CLOSED IN A DIFFERENT PLACE THAN THEY WERE BEFORE. NO VISIBLE DAMAGE FOUND ON THE CLAMP. NO OINTMENTS HAD BEEN USED. ASPIRATION AND FLUSH WERE DONE FOR BOTH LINES WITH 10ML OF SALINE PRIOR TO USE AND THE RESULT WAS NORMAL. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK OBSERVED. A COMPETITOR¿S MACHINE WAS BEING UTILIZED WITH THE DEVICE. THE INSERTION SITE WAS TREATED WITH DENATURED AND COLORED 80% ALCOHOL PRIOR TO PRODUCT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537111 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, NURSES FROM THE DIALYSIS WARD CAME TO PERFORM PLASMAPHERESIS ON THE PATIENT. UPON RINSING THE DIALYSIS CATHETER WHICH WAS MOST LIKELY DURING FINAL SALINE/HEPARIN FLUSH, THE PATIENT HAD BECOME UNWELL AND CONTINUED TO DEVELOP ASYSTOLE. RESUSCITATION PROCEDURES INCLUDING CHEST COMPRESSION, AND ADRENALINE 1MG HAD TO BE INITIATED. THE PATIENT'S CONDITION STABILIZED AFTER ABOUT 3-4 MINUTES. THE PLASMAPHERESIS HAD JUST BEEN PERFORMED. THE PATIENT HAD ALREADY UNDERGONE MULTIPLE PLASMAPHERESIS THROUGH THE SAME CATHETER WITHOUT ANY PROBLEMS. A CARDIOLOGIST PERFORMED ULTRASOUND AND FOUND THAT THERE WAS AIR IN THE RIGHT VENTRICLE OF THE HEART. AIR THROUGH THE CATHETER WAS BELIEVED TO BE THE SOURCE OF THE AIR EMBOLISM. THE DOCTOR IMMEDIATELY CAME TO THE SCENE, CHECKED THE DIALYSIS CATHETER, THE CLAMPS WERE IN PLACE AND CLOSED, NO AIR WAS VISIBLE IN THE CATHETER, AND BLOOD COULD NORMALLY BE ASPIRATED FROM THE CATHETER. CHEST COMPRESSION AND ADRENALINE 1MG WERE REQUIRED DUE TO THE AIR EMBOLISM. THE AIR EMBOLISM WAS RESOLVED. THE HCP (HEALTH CARE PROFESSIONAL) DID NOT THINK THAT THE EVENT WAS RELATED TO A CATHETER MALFUNCTION, BUT IT WAS NOT POSSIBLE TO FULLY VERIFY THIS

  Patient problems: Air Embolism; Asystole; Pneumonia; Unintended Radiation Exposure

  MAUDE report 14256655 ↗
• InjuryApr 15, 2022Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, AT THE END OF HEMODIALYSIS, THE NURSE ENDED DIALYSIS AS USUAL. THE TABLE WAS NOT SET TO TRENDELENBURG POSITION BECAUSE BREATHING WAS LABORIOUS FOR THE PATIENT. AT THE SAME TIME, THE PUMP ALERTED ABOUT A DRUG (UNKNOWN DRUG) AND NOTED THAT THE DIALYSIS CATHETER WAS ACCIDENTALLY NOT PROPERLY CLAMPED BY THE NURSE AND SAID THAT THE CLAMPS ALSO HAD AN ISSUE WHEREIN THEY SOMEHOW FELT A BIT AND POORLY LOOSE AND AIR WAS THEN DETECTED IN THE CATHETER. THE NURSE IMMEDIATELY ASPIRATED THE AIR BUT THE PATIENT DEVELOPED AN AIR EMBOLISM AND UNDERWENT RESUSCITATION. NOTHING UNUSUAL WAS OBSERVED DURING DIALYSIS. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE CLAMPS WERE SAID TO BE MOVED PERIODICALLY. DIALYSIS MACHINE WAS BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. IT WAS SAID THAT IN ORDER TO RESOLVE THE AIR EMBOLISM, PEA (PULSELESS ELECTRICAL ACTIVITY) RHYTHM AND 3MIN ROSC (RETURN OF SPONTANEOUS CIRCULATION), SECOND RESUSCITATION AND ROSC 2MIN WERE DONE. CT (COMPUTERIZED TOMOGRAPHY) SCAN WAS ACQUIRED AFTERWARDS AND THE RESULT WAS 1-2 HOURS AFTER THE EVENT, THERE WAS AIR IN THE CENTRAL

  Patient problems: Air Embolism

  MAUDE report 14119340 ↗

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.