MAHURKAR Elite 8888223213Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521125919), received between Sep 13, 2021 and Sep 13, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2021Break; Separation Problem; Break; Separation Problem

  ACCORDING TO THE REPORTER, FROM THE (B)(6) 2021, THE CVC (CENTRAL VENOUS CATHETER) LOCATED IN THE RIGHT JUGULAR VEIN WAS MALFUNCTIONING WHEREAS IT HAD PROBLEMS IN DOING DIALYSIS BOTH IN ASPIRATION AND ON RE-ENTRY. ON THE (B)(6) 2021, THEY PUT A TUNNEL/NEW CATHETER (COMPETITOR'S BRAND) AS INTERVENTION BUT IN ANOTHER SITE, IN THE LEFT SUBCLAVIAN AND THE PROCEDURE WAS COMPLETED. ON THE (B)(6) 2021, A CT (COMPUTED TOMOGRAPHY) SCAN WAS DONE FOR THE STUDY OF THE PATIENT'S VESSELS AND TO EVALUATE WHETHER TO MAKE A PROSTHESIS. ON THE (B)(6) 2021, THE CVC WAS REMOVED DUE TO THE MALFUNCTION, AFTER REMOVING THE CATHETER, THEY NOTICED THAT THE TIP WAS NOT PRESENT (DETACHED/MISSING), LATER, THEY NOTICED THROUGH THE CT SCAN THAT THE TIP OF THE CVC WAS WEDGED IN A SEGMENTAL BRANCH OF THE RIGHT PULMONARY ARTERIAL CIRCULATION. IT WAS STATED THAT THEY DID NOT KNOW HOW THE BREAK HAPPENED. NO EXCESSIVE FORCE USED TO PULL/TAKE OUT THE PRODUCT AND THE REMOVAL PROCEDURE WAS SAME AS ALWAYS. NOTHING ABNORMAL ABOUT THE PACKAGING PRIOR TO OPENING AND IMPLANTING THE CATHETER. NOTHING ABNORMAL ABOUT THE CATHETER OR KIT PRIOR TO IMPLANTING THE CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS

  Patient problems: Foreign Body In Patient

  MAUDE report 12459940 ↗

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.