LF 844007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10746190002727), received between Oct 24, 2024 and Dec 22, 2025 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Break; Break

  THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2025. CUSTOMER REPORTED THAT ON (B)(6) 2025, A PATIENT UNDERWENT CEREBRAL ARTERY CTA EXAMINATION FOR LEFT-SIDED PERIPHERAL FACIAL PARALYSIS. DURING THE PROCEDURE, HEALTHCARE PERSONNEL USED A HIGH-PRESSURE INJECTOR PRESSURE SLEEVE TO INJECT CONTRAST MEDIUM. PRIOR TO THE SCAN, ROUTINE INSPECTION OF THE DEVICE REVEALED NO ABNORMALITIES. HOWEVER, DURING INJECTION, THE PRESSURE SLEEVE SUDDENLY RUPTURED, FORCING AN INTERRUPTION OF THE PROCEDURE. THIS RUPTURE REMAINED WITHIN A CONTROLLABLE RANGE: THERE WAS NO SIGNIFICANT FRAGMENT SCATTER, AND NEITHER THE PATIENT NOR THE MEDICAL STAFF SUSTAINED VISIBLE INJURIES. IMMEDIATELY AFTER THE INCIDENT, THE STAFF STOPPED OPERATION, REPLACED THE FAULTY DEVICE WITH A BACKUP UNIT, AND RESUMED THE EXAMINATION. THE DEFECTIVE PRESSURE SLEEVE WAS SUBSEQUENTLY DECOMMISSIONED IN ACCORDANCE WITH REGULATIONS. THIS UNEXPECTED EVENT MAY HAVE RESULTED IN INSUFFICIENT CONTRAST VOLUME, COMPROMISING IMAGE QUALITY AND POTENTIALLY DELAYING DIAGNOSIS. HAD THE RUPTURE NOT BEEN PROMPTLY DETECTED, THE SCATTERING OF SHARP FRAGMENTS COULD HAVE INJURED HEALTHCARE WORKERS OR THE PATIENT, POSING A SERIOUS RISK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864621 ↗
• MalfunctionOct 24, 2024Pressure Problem; Pressure Problem

  THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) CHINA ON 25 SEPTEMBER 2024. DETAILS OF THE CASE ARE AS DESCRIBED BELOW: SETTING NAME: (B)(6). PRODUCT NAME: HIGH PRESSURE INJECTOR (OPTIVANTAGE DH) INJURY: SERIOUS INJURY MANIFESTATIONS: DRUG EXTRAVASATION, LOCAL SUBCUTANEOUS EDEMA AT THE INDWELLING NEEDLE LOCATION, AND OBVIOUS PAIN. INSTRUMENT FAILURE: HIGH PRESSURE INJECTOR PRESSURE IS NOT ACCURATE USE PROCESS: ON (B)(6) 2024, THE PATIENT UNDERWENT CTA IN THE ARTERIES OF BOTH LOWER LIMBS. THE RADIOLOGY NURSE FIRST CONDUCTED TWO UNBLOCKAGE TESTS, EACH WITH A VOLUME OF 5ML NORMAL SALINE AND A SPEED OF 4ML/S. THE PATIENT HAD NO LOCAL SWELLING WITH THE RETENTION NEEDLE AND NO SELF-REPORTED PAIN AND DISCOMFORT. NORMAL SCANNING AND INJECTION OF CONTRAST AGENT BEGAN AFTER THE END OF THE EXPERIMENT. WHEN THE SCAN WAS NEARLY HALF OVER, THE MACHINE ISSUED A HIGH PRESSURE ALARM, PROMPTING THE INJECTION TO CONTINUE OR STOP. AT THIS TIME, THE OPERATOR FOUND THAT ALMOST ALL THE INJECTION OF CONTRAST AGENT HAD BEEN COMPLETED, AND THE SCAN WAS COMPLETED AFTER THE INJECTION WAS STOPPED. AFTER THE PATIENT RETURNED TO THE WARD, THE DOCTOR GAVE MAGNESIUM SULFATE WET COMPRESS AND ICE TREATMENT, AND ON (B

  Patient problems: Administration Site Reaction; Extravasation; Pain

  MAUDE report 20522788 ↗

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