LF 900006CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10746190002802), received between Sep 25, 2024 and Aug 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K963071); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025No Display/Image; No Display/Image

  THIS CASE WAS REPORTED BY A FACILITY IN (B)(6), CHINA ON 07 JULY 2025. CUSTOMER REPORTS THAT AT AROUND 9 A.M. ON (B)(6) 2025, DURING THE PATIENT'S TREATMENT, THE HIGH-PRESSURE INJECTOR'S SCREEN WENT BLACK AND SHOWED ERROR CODE "0013". THE TECHNICIAN REBOOTED THE DEVICE SEVERAL TIMES, BUT STILL COULDN'T ENABLE THE SURGERY TO CONTINUE, SO THE SURGERY HAD TO BE SUSPENDED. PRODUCT NAME: HIGH-PRESSURE INJECTOR TYPE OF INJURY: SERIOUS INJURY MANIFESTATION: DURING A PATIENT'S CEREBRAL ANGIOGRAPHY PROCEDURE, THE HIGH-PRESSURE INJECTOR STOPPED WORKING DURING SURGERY, THE DEVICE WENT BLACK SCREEN AND PROMPT ERROR CODE "0013". AS A RESULT, THE SURGERY WAS SUSPENDED, AND THE PATIENT WILL NEED TO UNDERGO THE SURGERY AGAIN ON ANOTHER DAY. THIS INCIDENT SERIOUSLY ENDANGERED THE PATIENT'S LIFE SAFETY, CAUSING SECONDARY HARM AND NEGATIVELY IMPACTING THE HOSPITAL DEPARTMENT'S SURGERY AND REPUTATION. DEVICE MALFUNCTION PERFORMANCE: DURING THE SURGERY, THE HIGH-PRESSURE INJECTOR STOPPED WORKING. A BLACK SCREEN ERROR CODE "0013" APPEARED. THE DEVICE WAS REBOOTED SEVERAL TIMES, BUT IT STILL COULDN'T SUPPORT THE CONTINUATION OF THE SURGERY. IT KEPT TURNING ON BUT SHOWING A BLACK SCREEN WITH ERROR CODE "0

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716184 ↗
• MalfunctionSep 25, 2024Circuit Failure; Circuit Failure

  THIS CASE WAS REPORTED BY A FACILITY IN JINAN, CHINA ON 27 AUGUST 2024. REPORTER STATES THAT IN THE OPERATING ROOM, HIGH-PRESSURE INJECTION ANGIOGRAPHY IS PERFORMED WHEN THE PATIENT IS UNDERGOING ANGIOGRAPHY SURGERY. HOWEVER, THE DEVICE REPORTED AN ERROR, THE OPERATION FAILED, AND THE NORMAL INJECTION COULD NOT BE CARRIED OUT, RESULTING IN INCREASED BLOOD LOSS FOR THE PATIENT. THE STANDBY MACHINE WAS IMMEDIATELY USED TO SUCCESSFULLY COMPLETE THE OPERATION, WHICH EXTENDED THE OVERALL OPERATION TIME AND CAUSED DISSATISFACTION AMONG THE PATIENTS' FAMILIES. HOSPITAL ENGINEERS RUSHED TO THE SCENE AS SOON AS POSSIBLE TO DETECT AND TROUBLESHOOT TO FIND IT'S THE INTERNAL MOTHERBOARD PROBLEM. AFTER DISMANTLING THE MACHINE, REPAIRING AND SORTING OUT THE MOTHERBOARD LINE, THE EQUIPMENT DEBUGGING AND RUNNING NORMALLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20302311 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963071. One submission often covers many models, so check the product and lot details in each record.

• Z-2859-2011 · May 20, 2011 · Terminated
  Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe w
• Z-0056-2008 · Aug 24, 2007 · Terminated
  Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.