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Magic Infusion Catheter MAGIC1.2FRecalls & reported problems

Balt USA LLC · Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053022586), received between Jun 26, 2019 and Jun 30, 2020 — classified as 2 malfunctions.

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

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

Device problems

  • Break1
  • Fluid/Blood Leak1
  • Material Rupture1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

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

  • MalfunctionJun 30, 2020Material Rupture; Material Rupture

    IT WAS REPORTED THAT: "A TUMOR EMBO WHERE A 1.2F MAGIC RUPTURED WHILE INJECTING NBCA. USING A 1CC SYRINGE TO INJECT THE GLUE."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10213603 ↗
  • MalfunctionJun 26, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

    IT WAS REPORTED THAT: "I WAS NOT PRESENT AT THE CASE, BUT ON MY VISIT TO THE HOSPITAL ON (B)(6), DR. (B)(6) INFORMED ME THAT IN THE CASE ON (B)(6) THAT ONE OF THE TWO MAGIC CATHETERS USED RUPTURED NEAR THE TIP. THEY DID NOT SAVE THE CATHETER FOR INSPECTION. DR. (B)(6) COMMENTED THAT THE RUPTURE WAS SO CLOSE TO THE TIP, THAT IT DID NOT ADVERSELY EFFECT THE EMBOLIZATION OR PATIENT SAFETY. DR. (B)(6) SHARED THE LOT NUMBERS WITH ME, BUT WAS UNCERTAIN WHICH OF THE TWO CATHETER STICKERS BELONGED TO THE CATHETER THAT RUPTURED. DR. (B)(6) ADDED THAT THE PHYSICIAN WHO INJECTED THE GLUE USED A 3CC MEDALLION AND THAT THEY DID NOT HAVE A LOT OF EXPERIENCE USING GLUE."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8735214 ↗

Other Catheter, Continuous Flush devices

All Catheter, Continuous Flush devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.