MAHURKAR Elite 8888221224Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521125742), received between Jun 28, 2018 and Jun 12, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE CATHETER GAVE INSUFFICIENT BLOOD FLOW, AND THIS WAS OBSERVED IN THE TREATMENT. IT WAS STATED THAT THE CATHETER HAS BEEN IN PLACE FOR SEVENTEEN DAYS AT THE TIME OF THE EVENT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. IT WAS STATED THAT THE LINE WAS HARD TO FLUSH WITH THE SYRINGE AND THERE WAS NO BLOOD RETURN PRIOR TO SYRINGE FLUSH. ANTI COAGULATION (TPA, HEPARIN) WAS USED. THE REVERSE FLOW WAS NOT SUCCESSFUL. IT WAS STATED THAT THIS WAS THE INFUSION LINE. THERE WAS NO OCCLUSION OBSERVED ON THE REPORTED CATHETER. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE AND NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES OBSERVED ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION/INTERVENTION THE REPORTED PRODUCT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER¿S PRODUCT. THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106441 ↗
• MalfunctionJun 1, 2023Insufficient Flow or Under Infusion; Material Deformation; Insufficient Flow or Under Infusion; Material Deformation

  ACCORDING TO THE REPORTER, THE CATHETER WAS EXPLANTED BECAUSE IT DID NOT WORK DUE TO INSUFFICIENT FLOW (NO FLOW RATE) THEN AFTER EXPLANT, THEY SAW THAT THE CATHETER SHAFT/TIP HAD SMALL DEFORMATIONS. THE TIP OF THE CATHETER HAD A DEFORMED SUCTION HOLES. 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. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE KIT WAS UTILIZED WITH THE DEVICE. FLUSHING WAS DONE PRIOR TO USE AND HAD A NORMAL RESULT. ANTICOAGULANT WAS ADMINISTERED TO THE PATIENT. THE LINE WAS HARD TO FLUSH WITH THE SYRINGE AND LOW FLOW ISSUE WAS NOT DUE TO THROMBOSIS. THERE WAS NO BLOOD RETURN PRIOR TO SYRINGE FLUSH. REVERSE FLOW WAS NOT SUCCESSFULLY DONE AND THIS WAS THE INFUSION LINE. THE 300ML OF BLOOD LOSS WAS THE ONE INSIDE THE BLOOD LINE (EXTRACORPOREAL CIRCUIT) OF THE MACHINE TO DO DIALYSIS AND HAD TO THROW IT AWAY. BLOOD TRANSFUSION WAS NOT NEEDED. THERE WAS NO REMEDIAL ACTION DONE AND THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042081 ↗
• MalfunctionJun 28, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THEY COULDN'T THREAD THE CATHETER OVER THE GUIDE WIRE BUT THEY WERE PARTIALLY ABLE TO INSERT THE GUIDE WIRE THROUGH THE CATHETER. IT WAS STATED THAT FLUSHING OF THE CATHETER WAS PERFORMED PRIOR TO USE AND THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED. A SECOND INSERTION WAS DONE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7646032 ↗

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.