MAHURKAR Elite 8888221213Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521125704), received between Apr 3, 2018 and Jul 20, 2020 — classified as 1 injury, 2 malfunctions.

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

• InjuryJul 20, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE GUIDE WIRE SPLIT/BROKE AT THE MIDDLE PART WHEN IT WAS PULLED OUT AFTER PROPER INSERTION. HEALTHCARE PROFESSIONAL (HCP) WAS AFRAID THAT FOREIGN BODY WAS LEFT IN PATIENT'S BODY. THE PATIENT WAS THEN SENT TO THE INTENSIVE CARE UNIT (ICU) AND WAS SENT TO THE OPERATING THEATER THE NEXT DAY TO REMOVE THE DEVICE. THE GUIDE WIRE THAT CAME WITH THE KIT WAS USED. THERE WAS NO ABNORMAL CONDITION NOTED PRIOR TO BREAKING, NO EXCESSIVE FORCE WAS USED. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, ALCOHOL/IODINE BASED SOLUTION WAS THE CLEANING AGENT USED, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE. ALL PIECES WAS ACCOUNTED FOR AND IT WAS CONFIRMED THAT NO PIECE WAS LEFT INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10295932 ↗
• MalfunctionOct 23, 2018Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING USE, A TEAR IN ONE OF THE WINGS WAS DISCOVERED AFTER INSERTION OF THE CATHETER. IT WAS STATED THAT A NEW CATHETER WAS PLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7995204 ↗
• MalfunctionApr 3, 2018Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE DEVICE¿S INSERTION GUIDE WIRE WAS STUCK IN THE INTRODUCER NEEDLE LUMEN DURING THE PROCEDURE. THE WIRE COULD NOT BE MANIPULATED FORWARD AND BACKWARD. THE GUIDE WIRE WAS STILL INTACT WHEN IT WAS REMOVED WITH THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7392426 ↗

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.