LF 900001CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10746190002796), received between Oct 29, 2024 and Mar 30, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Connection Problem

  THIS CASE WAS REPORTED BY A FACILITY IN DONGYANG, CHINA ON 05 MARCH 2026. THE CUSTOMER STATES THAT ON (B)(6) 2025, DURING SURGERY IN THE INTERVENTIONAL CATHETERIZATION ROOM, THE HIGH-PRESSURE INJECTOR FAILED TO INJECT THE DRUG AS INSTRUCTED, RESULTING IN FREQUENT INTERRUPTIONS TO THE SURGERY, FAILURE TO COMPLETE THE SURGERY AS SCHEDULED, AND DELAYS IN THE SURGERY AND PATIENT TREATMENT. THE HIGH-PRESSURE INJECTOR FAILED TO INJECT THE DRUG AS INSTRUCTED AS THE INJECTOR HAD NO RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730449 ↗
• MalfunctionSep 16, 2025Circuit Failure; Circuit Failure

  THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2025. CUSTOMER REPORTS THAT AT 22:15 ON (B)(6) 2025, THE PATIENT WAS ADMITTED WITH A CHIEF COMPLAINT OF "DIZZINESS FOR 1 DAY" AND DIAGNOSED WITH: 1. MULTIPLE BRAIN INFARCTIONS; 2. HYPERTENSION GRADE 3 (VERY HIGH RISK); 3. TYPE 2 DIABETES MELLITUS; 4. CORONARY ARTERY ATHEROSCLEROTIC HEART DISEASE WITH CARDIAC FUNCTION CLASS . CRANIAL MAGNETIC RESONANCE ANGIOGRAPHY (MRA) REVEALED: 1. AN ANEURYSM IN THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY, WITH A RECOMMENDATION FOR FURTHER EXAMINATION; 2. MULTIPLE SMALL LESIONS BRAIN INFARCTIONS AND PARTIAL ENCEPHALOMALACIA LESIONS. AT 08:30 ON (B)(6) 2025, THE PATIENT UNDERWENT "PERCUTANEOUS ARTERIAL CATHETERIZATION FOR TOTAL CEREBRAL ANGIOGRAPHY + INTRACRANIAL ANEURYSM EMBOLIZATION" IN THE CATHETERIZATION LABORATORY. DURING THE OPERATION, THE HIGH-PRESSURE INJECTOR FAILED TO WORK NORMALLY. EVEN AFTER MULTIPLE RESTARTS, THE DEVICE REMAINED NON-FUNCTIONAL. THE MEDICAL ENGINEERING DEPARTMENT WAS IMMEDIATELY NOTIFIED TO FEED BACK THE ISSUE TO THE MANUFACTURER, AND THIS MALFUNCTION AFFECTED THE PROGRESS OF THE PATIENT'S OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064913 ↗
• MalfunctionJun 20, 2025Failure to Pump; Failure to Pump

  THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2025. CUSTOMER REPORTS THAT INJECTOR SUDDENLY MALFUNCTIONED AND FAILED TO LINKED, RESULTING IN AN INABILITY TO INJECT CONTRAST AGENT. INJURY: SEVERE INJURY MANIFESTATION: PROLONGED SURGERY TIME DEVICE FAILURE MANIFESTATION: UNUSABLE USAGE PROCESS: THE PATIENT UNDERWENT STENT-ASSISTED COIL EMBOLIZATION FOR INTRACRANIAL ANEURYSM UNDER GENERAL ANESTHESIA. DURING THE SURGERY, THE HIGH-PRESSURE INJECTOR SUDDENLY MALFUNCTIONED AND FAILED TO LINKED, RESULTING IN AN INABILITY TO INJECT CONTRAST AGENT. RESTARTING THE DEVICE WAS INEFFECTIVE. THE SURGERY WAS COMPLETED BY MANUALLY USING THE HIGH-PRESSURE INJECTOR TO INJECT DRUGS, PROLONGING THE PATIENT'S ANESTHESIA TIME. EVENT CAUSE ANALYSIS: PRODUCT-RELATED CAUSE (INCLUDING INSTRUCTIONS, ETC.) EVENT CAUSE ANALYSIS DESCRIPTION: SYSTEM FAILURE OF THE HIGH-PRESSURE INJECTOR INITIAL HANDLING SITUATION: CONTACTED ENGINEERS FOR MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297946 ↗
• MalfunctionApr 2, 2025Material Deformation; Material Deformation

  THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) CHINA ON 10 MARCH 2025. CUSTOMER REPORTS THAT ON THE AFTERNOON OF JANUARY 10, 2025, IN THE EMERGENCY DSA DEPARTMENT, THERE WAS A NEED TO RESCUE A PATIENT WHO HAD FALLEN FROM A HIGH PLACE AND SUFFERED MULTIPLE FRACTURES ALL OVER THE BODY WITH BLEEDING FROM ALL THE ORIFICES OF THE HEAD. ARTERIAL EMBOLIZATION HEMOSTASIS TREATMENT WAS CARRIED OUT UNDER THE DSA MACHINE. SUDDENLY, THE HIGH-PRESSURE INJECTOR MALFUNCTIONED AND COULD NOT INJECT THE CONTRAST MEDIUM. IN AN EMERGENCY, THE DOCTOR HAD TO INJECT THE CONTRAST MEDIUM MANUALLY. DUE TO THE HIGH ARTERIAL PRESSURE, THE BLOOD VESSELS WERE BLURRED AND IT WAS IMPOSSIBLE TO DETERMINE THE BLEEDING SITUATION. THE MALFUNCTION OF THE HIGH-PRESSURE INJECTOR FORCED THE DOCTOR TO INJECT THE CONTRAST MEDIUM MANUALLY, AND THE DOCTOR COULD NOT LEAVE THE DSA ROOM (ORIGINALLY THERE WAS NO NEED TO STAY WITHIN THE RADIATION RANGE), SO THE MEDICAL STAFF RECEIVED ADDITIONAL RADIATION, POSING A SAFETY RISK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753097 ↗
• MalfunctionOct 29, 2024Device Fell; Device Fell

  THIS CASE WAS REPORTED BY A FACILITY IN NINGBO, CHINA ON 30 SEPTEMBER 2024. DETAILS OF THE CASE ARE AS DESCRIBED BELOW: INJURY: SERIOUS INJURY. INJURY PERFORMANCE: THE MACHINE FELL APART IN-SITU, THE PATIENT WAS FAR AWAY SO THERE WAS NO INJURY BUT THE PATIENT WAS FRIGHTENED, WHILE THE OUTER FLESH OF THE THIGH OF THE TECHNICIAN WHO OPERATING THE MACHINE WAS SUBJECTED TO STRONG FRICTION, AND OTHER PERSONNEL WERE FRIGHTENED INSTRUMENT FAILURE PERFORMANCE: HIGH-PRESSURE INJECTOR IN NORMAL USE, SUDDENLY "CUT IN HALF" FRACTURE. EXPECTED THERAPEUTIC DISEASE OR EFFECT: FOR THE SUCCESSFUL IMPLEMENTATION OF RENAL ARTERY EMBOLIZATION AND ACCURATE DIAGNOSIS AND TREATMENT OF THE PATIENT'S CONDITION PROCEDURE OF APPLICATION: ON (B)(6) 2024, DURING THE EMBOLIZATION OF THE PROPER HEPATIC ARTERY, NEEDED TO USE A HIGH-PRESSURE INJECTOR TO INJECT CONTRAST AGENT THROUGH THE BLOOD VESSEL TO MAKE THE LOCAL LESION DEVELOPED UNDER RADIATION. IN THE PROCESS OF USING THE HIGH-PRESSURE INJECTOR, THE WORKING MACHINE PART OF THE HIGH-PRESSURE INJECTOR HAD "CUT IN HALF" FRACTURE, AND THE PATIENT WAS NOT PHYSICALLY HARMED DUE TO A CERTAIN DISTANCE FROM THE MACHINE, BUT WAS FRIGHTENED. WHILE THE OUTER FLESH OF TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20558152 ↗

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.