HyperFormTM 104-4770Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536005853), received between Apr 29, 2019 and Apr 29, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

Recent adverse event reports

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

• MalfunctionApr 29, 2019Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT OF HYPERFORM BALLOON RUPTURE DURING A PROCEDURE. THE PATIENT WAS UNDERGOING FLOW DIVERSION TREATMENT OF A RUPTURED BLISTER ANEURYSM IN OPHTHALMIC SEGMENT OF INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM WAS REPORTED TO HAVE A MAX DIAMETER AND A NECK DIAMETER OF 2MM. THE LANDING ZONE WAS 3.8MM DISTALLY AND 4.3MM PROXIMALLY. THE ANATOMY WAS REPORTED TO HAVE BEEN NORMAL IN TORTUOSITY. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS USED DURING THE DELIVERY OF THE DEVICES. DURING THE PROCEDURE, A HYPERFORM WAS USED. WHILE INFLATING, THE BALLOON RUPTURED AND LEAKED OF CONTRAST. THE BALLOON WAS REMOVED FROM THE BODY. ANGIO REVEALED NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8559720 ↗