MAHURKAR Elite 8888211416 (UDI 10884521126015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521126015), received between Jan 2, 2020 and Jan 17, 2020 — classified as 3 injuries.

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

• InjuryJan 17, 2020Material Frayed; Material Frayed

  ACCORDING TO THE REPORTER, THE GUIDEWIRE WAS UNRAVELED. THEY WERE ABLE TO PULL IT OUT OF THE PATIENT AND PERFORM A SCAN TO BE SURE THAT NOT WAS LEFT.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9601119 ↗
• InjuryJan 15, 2020Break; Break

  ACCORDING TO THE REPORTER, THE GUIDE WIRE THAT WAS USED FOR DIALYSIS CATHETER PLACEMENT KIT WAS BROKEN INTO PIECES WITH THE NEEDLE. IT WAS ALSO STATED THAT BOTH PIECES WERE RETRIEVED AND APPEAR INTACT.

  Patient problems: Foreign Body In Patient; No Information

  MAUDE report 9590878 ↗
• InjuryJan 2, 2020Break; Break

  ACCORDING TO THE REPORTER, THE GUIDE WIRE UNCOILED DURING INSERTION. IT WAS NOTED THAT THE TIP OF THE GUIDE WIRE BROKE OFF IN THE INSERTION NEEDLE WHEN RETRACTED BY THE PHYSICIAN. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. FLUOROSCOPY WAS USED TO CHECK IF ANY GUIDE WIRE PIECES WERE LEFT IN THE PATIENT AND IT WAS STATED TO BE NEGATIVE. THE KIT WAS REPLACED BY ANOTHER PRODUCT FROM A DIFFERENT MANUFACTURER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS NOTED ASSOCIATED WITH THE EVENT. THE PATIENT WAS REPORTED TO BE DECEASED. THE PATIENT'S DEATH WAS REPORTED NOT TO BE RELATED TO THE ALLEGED COMPLAINT.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9540472 ↗

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.