POWERFLEX 4400608XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032059562), received between Sep 26, 2019 and Oct 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO (6MM8CM 135) BALLOON CATHETER WAS USED FOR DILATATION. THE BALLOON WAS WORKING AT 10 ATMOSPHERIC PRESSURE (ATM), BURST PRESSURE AT 15 ATM. THE BALLOON BURST. THE PRESSURE PUMP WAS FILLED TO 6 ATM WAS BROKEN, THEN REPLACED WITH A 6*60MM, 10*60, AND 12*40MM POWERFLEX PRO BALLOON TO DILATE, AND A 14*80 SMART STENT WAS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE PATIENT HAD A HISTORY OF LEFT ILIAC VEIN COMPRESSION SYNDROME WITH 100% OCCLUSION. THE LEFT THIGH VEIN WAS PUNCTURED AND A NON-CORDIS GUIDE WIRE WAS USED OVER THE OCCLUSIVE SEGMENT. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). THE ACCESS SITE LOCATION WAS THE LEFT FEMORAL VEIN. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. VISPAQUE CONTRAST MEDIA WAS USED. THE CONTRAST TO SALINE RATIO WAS 1:1. A NON-CORDIS INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182747 ↗
• MalfunctionSep 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MMX8CM 135 POWERFLEX PRO "BALLOON BURST OUT OF VESSEL". THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9123151 ↗