MAHURKAR Elite 8888233224Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521127692), received between Apr 30, 2020 and Apr 30, 2020 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2020Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE RED PORT (ARTERIAL) CATHETER HAD A NARROW LOOP SITE THAT CAUSED DIALYSIS PRESSURE THAT WAS ALWAYS EXTREMELY HIGH AND TREATMENT ONLY LASTED 15 MINUTES AND HAD TO BE TERMINATED. IT WAS ALSO MENTIONED THAT LESS THAN 2 WEEKS PRIOR, A LEAK HAD DEVELOPED AND STARTED AT THE EXIT SITE ON THE ABDOMINAL WALL (1 YEAR AND 4 MONTHS AFTER IMPLANTATION) HOWEVER, THERE WERE NO OTHER DEFECTS/DAMAGES FOUND WHERE THE LEAK WAS OBSERVED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE AND IODINE WAS USED AS A CLEANING AGENT ON THE INSERTION SITE. POVIDONE IODINE AND MUPIROCIN OINTMENT WAS USED AS CLEANING AGENT ON THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO EXCESSIVE FORCE USED TO THE DEVICE. THE PATIENT WAS ON AN AUTOMATED PERITONEAL DIALYSIS (PD) CYCLER WHICH PERFORMS REGULAR DRAIN AND FILLS ON NORMAL PERITONEAL DIALYSIS, FOR WHICH THE CATHETER HAS BEEN DESIGNED. THERE WERE NO MANUAL FLUSHES PERFORMED, NO SPECIAL PD PROGRAMS WERE USED, AND NO MACHINE FAULTS OR ERROR MESSAGES WERE OBSERVED. NO PD CLAMPS WERE USED ON THE CATHETER AND THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE L

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10013620 ↗

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.