MAHURKAR Elite 8888231216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521126947), received between Jan 23, 2019 and Jan 23, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 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.

• DeathJan 23, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, DURING USE, ON CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) TREATMENT, PATIENT HAD A RESPIRATORY ARREST IN WHICH RESUSCITATION (CPR) WAS REQUIRED. IT WAS STATED THAT EVENTUALLY THE PATIENT RESPONDED TO TREATMENT, LEADING THE CLINICAL TEAM TO BELIEVE THAT THE TAMPONADE WAS NOT PRESENT AT THAT TIME. PATIENT THEN HAD ANOTHER RESPIRATORY ARREST IN WHICH CPR WAS REQUIRED ALONG WITH REINTUBATION AND DOCTOR PERFORMED A MEDIAN STERNOTOMY AT WHICH TIME HE SAW THE CATHETER PENETRATING THE ATRIUM. THE DOCTOR PUSHED THE CATHETER BACK IN AND USED THE PERFORATED OPENING FOR HIS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULATION. IT WAS REPORTED THAT ONGOING BLEEDING OCCURRED AND THE CATHETER WAS STILL OPPOSING THE ATRIAL WALL; THEREFORE, THE CATHETER WAS PULLED BACK AND RE-SECURED. IT WAS REPORTED THAT THE DEVICE REMAINED IN PLACE, BUT AS PER THE DOCTOR, THE PATIENT NEVER RECOVERED FROM THE ARRESTS NEUROLOGICALLY. AS A RESULT OF MULTIPLE CARDIAC ARRESTS (CARDIAC TAMPONADE) WHICH OCCURRED, THE PATIENT MET CRITERIA FOR BRAIN DEATH. IT WAS ALSO REPORTED THAT THE X-RAY OF CATHETER PLACEMENT INITIALLY SHOWED POSITIONING IN THE BOTTOM OF THE RIGHT ATRIUM. IT WAS UNCLEAR A

  Patient problems: Death

  MAUDE report 8272321 ↗

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.