MAHURKAR Elite 8888221316Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521126374), received between Aug 23, 2024 and Sep 17, 2024 — classified as 2 injuries.

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.

• InjurySep 17, 2024Insufficient Flow or Under Infusion; Separation Problem; Insufficient Flow or Under Infusion; Separation Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED WITH ALTERED MENTAL STATUS AND ACUTE KIDNEY INJURY, LATER DIAGNOSED WITH MICROANGIOPATHIC HEMOLYTIC ANEMIA. ON (B)(6) 2024, AN EXPERIENCED INTENSIVE CARE UNIT (ICU) PROVIDER INSERTED A LEFT INTERNAL JUGULAR DOUBLE LUMEN CENTRAL LINE CATHETER FOR PLASMAPHERESIS TREATMENT. THE PROVIDER FOLLOWED THE STANDARD ICU PRACTICE WITHOUT COMPLICATIONS. THAT NIGHT, DESPITE THE LINES FLUSHING WELL, THERE WAS POOR BLOOD RETURN AND SLUGGISH FLOW NOTED DURING PLASMAPHERESIS TREATMENT. THE APPROXIMATE AGE OF THE DEVICE WAS ONE DAY. THERE WAS NOTHING ODD NOTED ABOUT THE DEVICE WHEN REMOVED FROM PACKAGING. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. THE LINE WAS NOT HARD TO FLUSH WITH SYRINGE. NO ANTI COAGULATION WAS USED. NO CLEANING AGENT OF THE NEW PRODUCT/CATHETER WAS USED PRIOR TO INSERTION. CHLOROPREP SOLUTION ON PATIENT SKIN TO PREP PRIOR TO INSERTION. CONSEQUENTLY, THE ICU TEAM (DIFFERENT PROVIDER) DECIDED TO INSERT A SECOND DOUBLE LUMEN CENTRAL LINE CATHETER WITH THE SAME LOT NUMBER AND REMOVE

  Patient problems: Insufficient Information

  MAUDE report 20236291 ↗
• InjuryAug 23, 2024

  THE EVENT INVOLVED AN ELDERLY FEMALE WITH A PAST MEDICAL HISTORY OF THROMBOCYTOPENIA, HYPERTENSION, AND HYPERLIPIDEMIA. THE PATIENT WAS ADMITTED WITH ALTERED MENTAL STATUS AND ACUTE KIDNEY INJURY, LATER DIAGNOSED WITH MICROANGIOPATHIC HEMOLYTIC ANEMIA. ON [REDACTED DATE], AN EXPERIENCED INTENSIVE CARE UNIT (ICU) PROVIDER INSERTED A LEFT INTERNAL JUGULAR DOUBLE LUMEN CENTRAL LINE CATHETER FOR PLASMAPHERESIS TREATMENT. THE PROVIDER FOLLOWED THE STANDARD ICU PRACTICE WITHOUT COMPLICATIONS. THAT NIGHT, DESPITE THE LINES FLUSHING WELL, THERE WAS POOR BLOOD RETURN AND SLUGGISH FLOW NOTED DURING PLASMAPHERESIS TREATMENT. CONSEQUENTLY, THE ICU TEAM DECIDED TO INSERT A SECOND DOUBLE LUMEN CENTRAL LINE CATHETER AND REMOVE THE FIRST CENTRAL LINE CATHETER. THE REMOVAL OF THE LEFT INTERNAL JUGULAR CATHETER WAS PERFORMED AT THE ICU BEDSIDE PER THE STANDARD OF PRACTICE. THE ICU PROVIDER THAT REMOVED THE CATHETER INSPECTED AND NOTED THAT THE CATHETER TIP WAS INTACT. A CHEST COMPUTERIZED TOMOGRAPHY (CT) ON [REDACTED DATE] REVEALED A FOREIGN BODY IN THE RIGHT LOWER PULMONARY ARTERY. ON [REDACTED DATE] HAD THE FOREIGN BODY REMOVED WITHOUT COMPLICATIONS. THE FOREIGN BODY WAS DETERMINED TO BE A RETAINE

  Patient problems: Foreign Body In Patient

  MAUDE report 20047742 ↗

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.