MAHURKAR Elite 8888221216Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521125728), received between Jul 1, 2020 and Jan 29, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, WITHIN 48 HOURS OF INSTALLATION, THE CATHETER HAD DYSFUNCTION DUE TO HIGH-PRESSURE PROBLEMS. THIS RESULTED IN INADEQUATE BLOOD FLOW AND POOR DIALYSIS. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. REINSTALLING THE CATHETER WAS THE IMMEDIATE ACTION. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24211418 ↗
• MalfunctionJul 1, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, THE CATHETER SLID OUT OF THE SECUREMENT WING AND ONTO THE FLOOR. THE SECURING DEVICE WAS STILL SUTURED IN PLACE WITH BOTH SUTURES INTACT AND THE CATHETER WAS ALSO INTACT WHEN IT SLID OUT OF THE HOLDER. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. CHLORHEXIDINE WAS ROUTINELY USED TO CLEAN THE CENTRAL LINE SITES AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) BLOODLINES WAS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE DEVICE WAS NOT RETAINED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217457 ↗

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.