MAHURKAR Elite 8888223220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521125933), received between Feb 21, 2019 and Feb 27, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (4 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.

• MalfunctionFeb 27, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS NO VISIBLE SLIT ON THE DEVICES' REMOVABLE SUTURE WING. IT WAS STATED THAT THEY NEED TO OPEN THE WING BY SCALPEL BEFORE USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8375186 ↗
• MalfunctionFeb 27, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS NO VISIBLE SLIT ON THE DEVICES' REMOVABLE SUTURE WING. IT WAS STATED THAT THEY NEED TO OPEN THE WING BY SCALPEL BEFORE USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8375180 ↗
• MalfunctionFeb 27, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS NO VISIBLE SLIT ON THE DEVICES' REMOVABLE SUTURE WING. IT WAS STATED THAT THEY NEED TO OPEN THE WING BY SCALPEL BEFORE USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8373859 ↗
• MalfunctionFeb 21, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, CUSTOMER COMPLAINED THAT THE SUTURE WING COULD NOT BE FOLDED NORMALLY. IT WAS STATED THAT THE CATHETER WERE NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8357694 ↗

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.