MAHURKAR Elite 8888223216Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521125926), received between Sep 19, 2017 and Apr 19, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2024Product Quality Problem; Obstruction of Flow; Product Quality Problem; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS INSERTED ALONG THE GUIDE WIRE, BUT THE CATHETER STOPPED ADVANCING NEAR THE CATHETER "U" SHAFT BECAUSE THE GUIDE WIRE COULD NOT BE INSERTED MIDWAY THROUGH THE CATHETER (U SHAFT REGION), SO THE ENTIRE GUIDE WIRE WAS PULLED OUT FROM THE PATIENT. IT WAS CONFIRMED THAT THE CATHETER AND THE GUIDEWIRE WERE REMOVED TOGETHER MANUALLY. THE INSERTION PROCEDURE WAS PERFORMED AGAIN USING THE SAME PRODUCT FROM THE SAME LOT AND PRODUCT ID AT THE SAME DAY OF THE EVENT, AND IT SEEMS THAT PLACEMENT WAS POSSIBLE WITHOUT ANY PROBLEMS. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER REPLACING THE DEFECTIVE DEVICE WITH A NEW PRODUCT. WHEN THE GUIDEWIRE WHERE THE FIRST INCIDENT OCCURRED WAS CHECKED, IT WAS FOUND TO BE DEFORMED (BENT AND KINK). THE GUIDEWIRE USED WAS THE ONE INCLUDED IN THE KIT. THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE WITH NO PROBLEM. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON INSERTION AND WITHDRAWAL OF THE GUIDE WIRE. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THERE WAS NO INTERVENTION/MEDICAL TREATMENT RE QUIRED AS TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145126 ↗
• MalfunctionJun 11, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS INSERTED THROUGH THE LEFT INTERNAL NECK, THE CATHETER TIP GOT KINKED. IT WAS ALSO STATED THAT WHEN THEY REPLACED THE CATHETER WITH THE SECOND ONE, IT GOT KINKED AS WELL. THE CATHETER WAS REPLACED WITH A 25 CM (CENTIMETER) TRIPLE-LUMEN AS THE MEDICAL INTERVENTION DONE TO THE PATIENT. THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA, BLOOD TRANSFUSION WAS NOT NEEDED, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE PRIOR TO USE AND NO ABNORMALITY WITH THE RESULT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142552 ↗
• 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 8373856 ↗
• 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 8373855 ↗
• 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 8373853 ↗
• 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 8357761 ↗
• 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 8357760 ↗
• MalfunctionSep 19, 2017Hole In Material; Hole In Material

  THE CUSTOMER STATES AFTER INSERTION OF THE CATHETER THE NURSES PUT ON THE DRESSING AS NORMAL. THE SECOND DAY, WHEN THE NURSE OPENED THE DRESSING TO START THE FIRST DIALYSIS TREATMENT, THE ARTERIAL/RED EXTENSION WAS FOUND TO BE BROKEN AT THE CLAMP SITE. THE CATHETER WAS REPLACED WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6875302 ↗

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.