LF 844005Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10746190002710), received between Dec 9, 2024 and Jun 19, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K063503); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Air/Gas in Device

  THIS CASE WAS REPORTED BY A FACILITY IN BRAZIL ON 28 MAY 2026. THE CUSTOMER STATES THAT AIR WAS INJECTED INTO THE PATIENT INSTEAD OF CONTRAST.

  Patient problems: Air Embolism

  MAUDE report 25561976 ↗
• MalfunctionMay 19, 2026Break

  THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2026. THE CUSTOMER STATES THAT AT 8:30 A.M. ON (B)(6) 2026, PATIENT UNDERWENT LOWER LIMB CTA EXAMINATION. WITH THE CONTRAST MEDIUM FLOW RATE SET AT 1.0, THE SLEEVE OF THE HIGH-PRESSURE INJECTOR RUPTURED. AFTER THE ABNORMALITY WAS DETECTED, THE SLEEVE WAS REPLACED IMMEDIATELY TO CONTINUE THE EXAMINATION. THE INCIDENT CAUSED THE PATIENT TO FEEL FRIGHTENED, AND THE REPEATED EXAMINATION RESULTED IN INCREASED RADIATION EXPOSURE. THE FAULTY DEVICE WAS IMMEDIATELY DISCONTINUED AND REPLACED, AND THE EXAMINATION WAS FINALLY COMPLETED.

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

  MAUDE report 25219082 ↗
• InjuryOct 21, 2025Air/Gas in Device; Air/Gas in Device

  THIS CASE WAS REPORTED BY A FACILITY IN PARIS, FRANCE ON (B)(6) 2025. CUSTOMER REPORTED THAT THEY WERE INFORMED BY OTHER INDIVIDUALS THAT DURING THE PRIVATE FRIDAY MORNING SESSION AT THE (B)(6), A PATIENT HAD TO BE EVACUATED DUE TO BUBBLES IN THE OPTIVANTAGE INJECTOR. THE PATIENT UNDERWENT A CONTRAST-ENHANCED CT SCAN OF THE ENT AREA. THE SCAN REVEALED AIR BUBBLES IN THE PULMONARY ARTERIES, AS OBSERVED BY THE DOCTOR. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL AND HOSPITALIZED FOR TWO DAYS. HE RECEIVED HYPERBARIC CHAMBER TREATMENT AND FULLY RECOVERED WITHOUT ANY LASTING EFFECTS FROM THE INCIDENT. THE PURGE WAS PERFORMED AND CONFIRMED BY THE RADIOLOGY TECHNICIAN TO THE DOCTOR AT THE TIME OF THE INCIDENT.

  Patient problems: Air Embolism

  MAUDE report 23351267 ↗
• MalfunctionMar 20, 2025Inaccurate Delivery; Inaccurate Delivery

  THIS INCIDENT WAS REPORTED BY A FACILITY (B)(6), BRAZIL ON DATE FEBRUARY24, 2025. REPORTER INFORMED THAT "CONTRAST EXTRAVASATION. EIGHT INCIDENTS OF CONTRAST EXTRAVASATION WERE REPORTED IN FEBRUARY. THE ASSEMBLY OF THE CIRCUIT AND THE ENTIRE PROCESS UP TO THE PATIENT HAVE ALREADY BEEN CHECKED, AND IN VIEW OF THIS, WE REQUEST AN URGENT CHECK OF THE EQUIPMENT."

  Patient problems: Extravasation

  MAUDE report 21654029 ↗
• InjuryMar 10, 2025Air/Gas in Device; Air/Gas in Device

  THIS CASE WAS REPORTED BY A FACILITY IN FRANCE ON (B)(6) 2025. CUSTOMER STATES THAT ON (B)(6)2025 THAT AFTER THE INJECTION OF OPTIRAY 350 USING THE OPTIVANTAGE INJECTOR, AIR WAS INJECTED. TREATMENT AND MANAGEMENT OF THE PATIENT FOLLOWING THIS INJECTION OF AIR BUBBLES: EXTENDED 15L 02 SENT TO THE (B)(6).

  Patient problems: Air Embolism

  MAUDE report 21566665 ↗
• InjuryDec 9, 2024Air/Gas in Device; Air/Gas in Device

  THIS CASE WAS REPORTED BY A FACILITY IN FRANCE ON (B)(6) 2024. CUSTOMER STATES THAT THERE WAS THE PRESENCE OF AIR BUBBLES WHEN READING IMAGES.

  Patient problems: Air Embolism

  MAUDE report 20879973 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063503. One submission often covers many models, so check the product and lot details in each record.

• Z-1694-2008 · Apr 7, 2008 · Terminated
  The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images w