Magic Infusion Catheter MAGIC1.2FMRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053022593), received between Jun 18, 2019 and Aug 23, 2019 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathAug 23, 2019Off-Label Use; Off-Label Use

  MEDWATCH REPORT WAS RECEIVED VIA US MAIL ON AUGUST 8, 2019. DURING EMBOLIZATION OF AN ARTERIOVENOUS MALFORMATION (AVM} WITH ONYX, STAFF NOTED THE ONYX WAS LEAKING OUT OF THE MID-PORTION OF THE MAGIC 1, 2FM CATHETER DURING THE 3RD INJECTION. THE ONYX SHOULD EXIT THE CATHETER AT THE TIP, NOT FROM THE MID-PORTION. THE PHYSICIAN HAD TO EMPLOY A SOLITAIRE DEVICE AND USE ASPIRATION TO RETRIEVE THE ONYX. PER THE OP NOTE, APPROXIMATELY 60% WAS RECAPTURED. A 2ND PHYSICIAN WAS CALLED IN TO ASSIST. MDS WORKED APPROXIMATELY 2.5 HOURS TO CORRECT THE ISSUE. ATTEMPTS WERE EVENTUALLY STOPPED TO PREVENT FURTHER HARM TO THE PATIENT. AS A RESULT OF THE EVENT, THE PATIENT HAS A LARGE RIGHT FRONTAL STROKE. SINCE THE EVENT, HE HAS DEVELOPED AN INTRACRANIAL HEMORRHAGE REQUIRING A CRANIECTOMY FOR DECOMPRESSION & HEMATOMA EVACUATION. HE REMAINS IN ICU WITH A POOR NEUROLOGICAL EXAM AND POOR PROGNOSIS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PER STAFF REPORT, THE ONXY IS INJECTED VIA THE MAGIC L,2FM CATHETER. IT SHOULD EXIT THE CATHETER AT THE TIP END, NOT FROM THE MID-PORTION. THE CATHETER WAS RETAINED. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY} :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO

  Patient problems: Death

  MAUDE report 8928471 ↗
• MalfunctionJun 26, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT: "I DON'T KNOW ANY DETAILS ON THE CASE. THE CATHETER TIP BROKE IN 3 PIECES. PLEASE REPLACE CATHETER TO HOSPITAL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735215 ↗
• MalfunctionJun 18, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT: "TWO INCIDENCES INVOLVED. FIRST CASE INVOLVED A CATHETER TIP DETACHING DURING NBCA INJECTION. AT TIME OF THIS REPORT, I DID NOT GET TO SPEAK TO DOCTOR DIRECTLY. INFO IS SECOND HAND FROM TECHNOLOGIST. SECOND CASE INVOLVED A CATHETER THAT TECHNOLOGIST CLAIMED WAS 'SQUIRTING OUT FROM THE SIDE OF THE CATHETER DURING PREP.' PRODUCT WAS NOT USED IN PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8710127 ↗