POWERFLEX 4401206SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032060193), received between Dec 19, 2016 and Jul 19, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 16, 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.

• MalfunctionJul 19, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO PTA BALLOON CATHETER (12MM6CM 80) RUPTURED AT 12-ATMOSPHERES PRESSURE (ATM). THE BALLOON POPPED AND CAME OUT FULLY INTACT. THERE WAS NO REPORTED PATIENT INJURY. INITIALLY, THIS WAS A FISTULAGRAM CASE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807956 ↗
• InjuryMar 3, 2017Burst Container or Vessel; Detachment Of Device Component; Burst Container or Vessel; Detachment Of Device Component

  IT WAS REPORTED THAT A POWER FLEX PRO BALLOON RUPTURE AND THE DEVICE SEPARATED IN THE BODY. THE DOCTOR OPENED THE LEG AND REMOVED THE SEPARATED PIECE OF THE POWER FLEX PRO. THE PATIENT WAS NOT INJURED. AFTER THE STENT DEPLOYMENT, A POWER FLEX PRO WAS USED TO POST DILATE A STENT THAT WAS ALREADY PLACED IN WITH RESTENOSIS. THE POWER FLEX PRO WAS INSERTED AND INFLATED, HOWEVER, IT BURST. WHEN THE DOCTOR TRIED TO REMOVE IT, IT GOT STUCK SO THE DOCTOR PULLED IT AND IT BROKE IN THE BODY (THE SHAFT OF THE PTA). THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE BRAND OF INFLATION DEVICE THAT WAS USED IS BSX. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE CONTRAST MEDIA USED IS UNKNOWN BUT TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6377082 ↗
• MalfunctionDec 19, 2016Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED A POWER FLEX PRO BALLOON BURST AT RBP WHILE ATTEMPTING TO EXPAND THE VESSEL. THERE WAS NO PATIENT INJURY. THE PATIENT WAS DIAGNOSED WITH INFERIOR VENA CAVA STENOSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6186056 ↗