POWERFLEX 4400506XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032059357), received between Oct 7, 2019 and Aug 12, 2022 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 12, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN TRYING TO INFLATE THE POWERFLEX PRO 5MM 6CM BALLOON, THE BALLOON BURST. THE BALLOON WAS NOTED TO HAVE RUPTURED WHILE IN THE VESSEL THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS DONE NORMALLY. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INFLATION DEVICE WAS FILLED WITH A 50/50 CONTRAST/SALINE RATIO. THAT SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING THE CASE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE DEVICE WAS NEVER IN AN ACUTE BEND. THE DEVICE WAS NEVER KINKED WHILE BEING USED. THE DEVICE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215239 ↗
• MalfunctionOct 7, 2019Leak/Splash; Leak/Splash

  AS REPORTED, THE POWERFLEX PRO 5MM6CM 135 WOULD NOT HOLD PRESSURE, IT APPEARED TO BE LEAKING. THERE WERE NO REPORTED PATIENT INJURIES. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9163708 ↗