MAHURKAR Elite 8888211420 (UDI 10884521126022)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521126022), received between May 13, 2019 and Nov 9, 2021 — classified as 3 malfunctions.

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.

• MalfunctionNov 9, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING INTRAVENOUS (IV) INSERTION, THE CATHETER WAS CRACKED. IT WAS MENTIONED THAT THE REST OF THE KIT WAS FINE AND THE PRODUCT WAS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. THEY HAD TO OPEN ANOTHER KIT IN PROCEDURE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12779049 ↗
• MalfunctionJul 9, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE KIT WAS OPENED AND THE CATHETER WAS CRACKED. THERE WAS A LEAK AT THE CATHETER SHAFT (AT THE JUNCTION OF THE BIFURCATE AND CATHETER). THE REST OF THE KIT WAS FINE. THE CATHETER WAS NOT REPAIRED AND NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THEY HAD TO OPEN ANOTHER KIT WHILE IN PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147767 ↗
• MalfunctionMay 13, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PLACEMENT, WHEN THE DEVICE WAS INTRODUCED, ITS WIRE BECAME KINKED UPON REMOVAL AND BEGAN TO UNRAVEL, BOTH THE NEEDLE AND THE WIRE WAS REMOVED. THE 2ND DEVICE WAS THEN DELIVERED THEY THEN MOVED THE WIRE UP AND DOWN WHILE INSIDE THE INTRODUCER NEEDLE AND AS THE WIRE WAS PULLED BACK UP, THE NEEDLE BECAME TANGLED IN THE WIRE AND THEN BECAME LODGED AT THE TIP OF THE NEEDLE PUNCTURING THE WIRE THUS THE WIRE WENT INTO THE WIRE. BOTH THE WIRE AND THE NEEDLE WAS REMOVED. BOTH DEVICES WERE CLEANED WITH CHLOROPREP FROM PASS TRAY AND THERE WAS NO LUER LOCK ADAPTER ISSUE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8604656 ↗

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.