HyperForm 104-4770 (UDI 00836462004207)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00836462004207), received between Sep 18, 2019 and Mar 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE PREPARATION WAS PERFORMED ACCORDING TO THE PACKAGE INSERT, BUT HYPER FORM BALLOON DAMAGE WAS OBSERVED, SO THE PRODUCT WAS REPLACED WITH A NON-MEDTRONIC DEVICE AND THE TREATMENT WAS SUCCESSFULLY COMPLETED. THERE WAS NO SUPERVISION AND NO HEALTH DAMAGE. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS RELATED TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE EVENT OCCURRED DURING SETUP PRIOR TO USE. THE REPORTED BALLOON DAMAGE WAS IDENTIFIED AS A RUPTURE, WHICH OCCURRED NEAR THE TIP OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489341 ↗
• MalfunctionDec 9, 2020Burst Container or Vessel; Display or Visual Feedback Problem; Burst Container or Vessel; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED A REPORT THAT THE HYPERFORM BALLOON HAD POOR VISUALIZATION USING IMAGING. IT WAS REPORTED THAT ADVANCE PREPARATION WAS CARRIED OUT AND THE INFLATION WAS CHECKED OUTSIDE OF THE PATIENT'S BODY WITHOUT PROBLEMS UNDER FLUOROSCOPY IN ORDER TO INFLATE AFTER THE PIPELINE WAS PLACED. THE BALLOON WAS INFLATED IN THE DESIRED SITE; HOWEVER, IT COULD NOT BE CONFIRMED VISUALLY. AS INFLATION WAS NOT CERTAIN AFTER SEVERAL ATTEMPTS TO DO SO, THE BALLOON WAS COLLECTED AS THERE WAS DAMAGE ON THE BALLOON WHEN IT WAS COLLECTED AND CHECKED OUTSIDE OF THE PATIENT'S BODY. THE OPERATION WAS PERFORMED WITH NO PROBLEMS WHEN DELIVERING THROUGH BLOOD VESSELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10977811 ↗
• MalfunctionJul 13, 2020Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE STENT DEVICE THAT FAILED TO OPEN. WHEN RETRIEVING FAILED PIPELINE, IT BECAME STUCK AT THE DISTAL END OF THE PHENOM CATHETER. A HYPERFORM BALLOON RUPTURED DURING THE SAME PROCEDURE AFTER THE PIPELINE DEPLOYMENT FAILURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED 28MM FUSIFORM ANEURYSM OF THE INTERNAL CAROTID ARTERY. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT A NAVIEN INTRACRANIAL SUPPORT CATHETER WAS NAVIGATED TO THE ANEURYSM SITE. THE PHENOM CATHETER AND GUIDE WIRE WERE THEN NAVIGATED TO THE DISTAL NECK OF THE ANEURYSM. THE PIPELINE WAS DELIVERED TO THE TIP OF THE PHENOM MICROCATHETER. HOWEVER PIPELINE DEPLOYMENT FAILED. WHEN TRYING TO RETRIEVE THE PIPELINE, SIGNIFICANT RESISTANCE WAS FELT WITH THE PIPELINE AT THE DISTAL END OF THE PHENOM MICROCATHETER SO THE DEVICES WERE REMOVED TOGETHER. AFTER PIPELINE DEPLOYMENT FAILURE, USE OF A HYPERFORM BALLOON WAS ATTEMPTED BUT THE BALLOON RUPTURED. THE BALLOON WAS REPLACED WITH A NON-MEDTRONIC BALLOON AND AFTERWARD 4 PIPELINE STENTS WERE SUCCESSFULLY PLACED TO COMPLETE THE PROCEDURE. ALL DEVICES WERE PREPARED AND CATHETERS FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10267795 ↗
• MalfunctionSep 18, 2019Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED REPORT THAT DURING THE PREPARATION, THE BALLOON WAS NOTED TO BE BROKEN AND WAS NOT USED TO TREAT THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9084692 ↗