MAHURKAR Elite 8888211224Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521125391), received between Dec 9, 2022 and Nov 20, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Break; Defective Component; Break; Defective Component

  ACCORDING TO THE REPORTER, WHEN SEALING THE TUBE RIGHT AFTER THE IMPLANTATION, IT WAS FOUND THAT THE INNER DIAMETER OF THE EXTERNAL ARTERIAL (RED) CONNECTOR AND VENOUS (BLUE) CONNECTOR WAS LARGER THAN THAT OF THE CATHETER USED IN THE PAST, WHICH CAUSED THE SYRINGE AND THE EXTERNAL CONNECTOR TO NOT BE TIGHTLY CONNECTED, AND RESULTED IN THE RISK OF BLOOD, FLUID AND AIR LEAKAGE. IT WAS ALSO STATED THAT THERE WAS A LEAK LOCATED AT THE VENOUS (BLUE) LUER ADAPTER, AND NO CRACK WAS OBSERVED WITH 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 WHERE THE LEAK WAS OBSERVED. FLUSHING WAS DONE PRIOR TO USE WITH NO PROBLEM WITH THE RESULT. TEGO WAS NOT UTILIZED, AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE ADAPTERS WERE TIGHTENED BY HAND. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE, AND THERE WAS NO CLEANING AGENT UTILIZED TO CLEAN THE ADAPTERS. THE INSERTION SITE WAS NOT HANDLED PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE CAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18176743 ↗
• MalfunctionMay 25, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE REPORTED HIGH FLOW 13.5FR X 20 CM JUGULAR CATHETER WAS INSTALLED TO THE PATIENT. IN THE EIGHTH PLASMAPHERESIS SESSION, THE THERAPY WAS NOT MODIFIED WITH ANY OF THE 4 TEAMS THAT THEY MANAGE AS A CLINIC (2 DIAPAC ¿ 2 OMNI) SINCE THEY PRODUCED PRESSURE FAILURES. SO, ANOTHER HIGH FLOW 13.5 FR X 24 CM CATHETER WAS INSTALLED, BUT THE RESULT WAS THE SAME AND THE PATIENT DID NOT REINFORCE THE 10 PLASMAPHERESIS SESSIONS. THE CATHETER WAS NOT REPAIRED. THE REPORT ISSUED BY ANOTHER COMPANY AFTER THE ANALYSIS OF THE EQUIPMENT MENTIONED THAT THE FAILURE WAS DUE TO EXTERNAL FACTORS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007223 ↗
• MalfunctionMay 25, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE REPORTED HIGH FLOW 13.5FR X 20 CM JUGULAR CATHETER WAS INSTALLED TO THE PATIENT. IN THE EIGHTH PLASMAPHERESIS SESSION, THE THERAPY WAS NOT MODIFIED WITH ANY OF THE 4 TEAMS THAT THEY MANAGE AS A CLINIC (2 DIAPAC ¿ 2 OMNI) SINCE THEY PRODUCED PRESSURE FAILURES. SO, ANOTHER HIGH FLOW 13.5 FR X 24 CM CATHETER WAS INSTALLED, BUT THE RESULT WAS THE SAME AND THE PATIENT DID NOT REINFORCE THE 10 PLASMAPHERESIS SESSIONS. THE CATHETER WAS NOT REPAIRED. THE REPORT ISSUED BY ANOTHER COMPANY AFTER THE ANALYSIS OF THE EQUIPMENT MENTIONED THAT THE FAILURE WAS DUE TO EXTERNAL FACTORS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007213 ↗
• MalfunctionDec 9, 2022Break; Material Deformation; Break; Material Deformation

  ACCORDING TO THE REPORTER, FOLLOWING REPEATED ALARMS FROM THE MONITOR AND THE INEFFECTIVENESS OF THE PATIENT'S TREATMENT, THE RESUSCITATOR (PHYSICIAN) DECIDED TO CHANGE THE EXTRA-RENAL PURIFICATION CATHETER PLACED IN THE FEMORAL. WHEN IT WAS REMOVED, THE CATHETER WAS BENT, TORN OFF ON ONE PART. EVIDENCE OF A RECIRCULATION PHENOMENON IN THE EXTRA-RENAL PURIFICATION CIRCUIT WITH TREATMENT INEFFICIENCY FOLLOWED BY PREMATURE COAGULATION OF THE CIRCUIT FILTER. CHANGE OF THE CATHETER CARRIED OUT QUICKLY TO BE ABLE TO RE-INITIATE AN EFFECTIVE TREATMENT BY CONTINUOUS HEMOFILTRATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15952416 ↗

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.