POWERFLEX 4401008XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032060100), received between Nov 1, 2021 and Apr 13, 2022 — classified as 1 injury, 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. 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.

• InjuryApr 13, 2022Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 10MM X 8CM 135CM POWERFLEX PRO .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION TO 12 ATMOSPHERES (ATM) IN THE ILIAC VEIN. AFTER THE RUPTURE, THE POWERFLEX PRO WAS DIFFICULT TO REMOVE. TO REMOVE THE POWERFLEX PRO PTA BALLOON CATHETER, TRANSECTION OF THE DEVICE WAS REQUIRED, AND AN INCISION AT THE PUNCTURE SITE WAS MADE. ONCE THE BALLOON WAS REMOVED, THE PATIENT WAS OBSERVED UNTIL STABILIZATION AND THE PROCEDURE WAS ENDED. THE POWERFLEX PRO WAS BEING USED TO TREAT ILIAC VEIN IN-STENT RESTENOSIS WHICH WAS NOT REPORTED AS A CHRONIC TOTAL OCCLUSION (CTO). THE ILIAC VEIN HAD A 75% PERCENT STENOSIS AND SHOWED NO SIGNS OF CALCIFICATION OR TORTUOSITY. THE DEVICE WAS STORED AND PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR ANY OF THE STERILE PACKAGING COMPONENTS. HENGRUI CONTRAST WAS USED, AND THE DEVICE WAS PREPARED AT A 1:1 CONTRAST TO SALINE RATIO. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED WHILE THE BALLOON WAS BEING INSERTED INTO THE PATIENT, THE BALLOON WAS ABLE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14100973 ↗
• MalfunctionNov 1, 2021Leak/Splash; Leak/Splash

  DURING THE PURGING OF A 10MM X 8CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER ON THE TABLE, IT WAS OBSERVED THAT A JET OF WATER CAME OUT OF THE SHAFT OF THE BALLOON. THEREFORE, IT WAS NOT USED IN THE PATIENT AND A NEW POWERFLEX BALLOON (UNKNOWN) WAS USED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER THE INSTRUCTIONS FOR USE (IFU) AND WAS OPEN IN A STERILE FIELD. THE INTENDED PROCEDURE WAS A BILIARY ANGIOPLASTY. THE LESION WAS NOT CALCIFIED. THERE VESSEL WAS SLIGHTLY TORTUOUS. THE PERCENTAGE OF STENOSIS WAS MILD. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE DEVICE WILL BE RETURNED FOR EVALUATION. PHOTOGRAPHS WERE PROVIDED AND AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728216 ↗