MEDRAD® Spectris Solaris EP MR Injection SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00616258020280), received between May 20, 2021 and May 20, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THE FOLLOWING: AN (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN MRI SCAN OF THE ABDOMEN WITH INTRAVENOUS CONTRAST INJECTION WHILE CONNECTED TO A MEDRAD® SPECTRIS SOLARIS EP INJECTION SYSTEM. THE SITE REPORTED THAT DURING THE MR SCAN THE PATIENT PUSHED THE "PATIENT CALL" BUTTON TO ALERT THE STAFF OF A CHANGE IN THEIR CONSCIOUSNESS. THE SITE IMMEDIATELY REMOVED THE PATIENT FROM THE MRI SCANNER AND SENT THE PATIENT FOR AN UNENHANCED CT OF THE HEAD. THE CT IMAGES SHOWED A LOW INTENSITY AREA, INTERPRETED AS APPROXIMATELY 8 ML OF ALLEGED AIR. THE SITE CONFIRMED THAT THE ALLEGED AIR DISAPPEARED 2.5 HOURS LATER. THE PATIENT WAS REPORTED TO TEMPORARILY RECOVER AFTER THE ADMINISTRATION OF CERCINE (DIAZEPAM), AND THEN DECLINED ONCE AGAIN. THE PATIENT IS REPORTED TO BE HOSPITALIZED AT THIS TIME. NO FURTHER PATIENT INFORMATION IS AVAILABLE. ADDITIONAL CORRESPONDENCE WITH THE CUSTOMER INDICATED THAT THE SITE IS UNABLE TO CONFIRM WHETHER THE LOW-PRESSURE CONNECTOR TUBING WAS PRIMED AND FREE OF AIR PRIOR TO THE PATIENT CONNECTION AND THE START OF THE PROCEDURE.

  Patient problems: Air Embolism

  MAUDE report 11856474 ↗