MAHURKAR Elite 8888233213Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521127654), received between Sep 16, 2022 and Sep 16, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjurySep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, LEFT GROIN CATHETER WITH PIG-TAIL WAS IN PLACE AND ACTIVELY BEING USED FOR CVVHD (CVVHD (CONTINUOUS VENO-VENOUS HEMODIALYSIS) WITH LEVOPHED, KVO/IVF (KEEP VEIN OPEN/INTRAVENOUS FLUID) BOLUS INFUSING VIA A 1-STOP-COCK SET-UP. THE PATIENT'S CATHETER WAS USUALLY VISIBLE TO INFUSION RN (REGISTERED NURSE) WHILE TREATMENT WAS RUNNING HOWEVER, THIS PARTICULAR DAY, MD (MEDICAL DOCTOR) WAS PLACING A L-RADIAL-ALINE- (LEFT RADIAL ARTERIAL LINE) AND DURING THE PROCEDURE, THE MD'S STERILE FIELD WAS PLACED IN SUCH A WAY, THAT THE PATIENT'S CATHETER WAS NO LONGER VISIBLE FOR ASSESSMENT. DURING CRRT TREATMENT, PATIENT¿S BP (BLOOD PRESSURE) WAS TRENDING DOWN, THIS WAS NOT ALARMING TO THEM (CAREGIVERS), AS, PATIENT BPS TRENDS HAD BEEN CONSISTENTLY LABILE. SUBSEQUENTLY, THE PATIENT RECEIVED AN LR (LACTATED RINGER) BOLUS AND HIS PRESSOR REQUIREMENT WAS MARKEDLY INCREASED. AT THE END OF THE CRRT TREATMENT, AS THE MD CLEARED HIS STERILE FIELD, THERE WAS A LARGE COLLECTION OF BLOOD AND FLUIDS NOTED ON THE PERI-PAD BENEATH THE PATIENT. UPON FURTHER ASSESSMENT, THE END OF THE PIGTAIL HAD BROKEN OFF THE CATHETER ITSELF. THE PIGTAIL LUMEN WAS COMPLETELY SEPARATED FROM THE TUBING. A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15442172 ↗

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.