POWERFLEX 4400806XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032059845), received between Apr 21, 2017 and Aug 5, 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.

• MalfunctionAug 5, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN A BALLOON DILATION WAS PERFORMED WITH A POWERFLEX PRO PTA BALLOON CATHETER (8MM6CM 135), IT WAS FOUND THAT THE BALLOON WAS RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8862210 ↗
• MalfunctionApr 21, 2017Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION WAS RECEIVED AND DURING THE EVALUATION OF THE DEVICE; THE BALLOON DEVICE WAS INFLATED AND 3CM AXIAL BURST WAS OBSERVED AT THE DISTAL SECTION OF THE BALLOON. AS REPORTED, THE POWER FLEX PRO 8MM 6CM 135 BALLOON WAS INSERTED INTO BODY-VESSEL-POSITION. DURING INFLATION, PHYSICIAN NOTICED AIR ON PROXIMAL END OF BALLOON WHERE THE BALLOON WAS NOT INFLATING AND GETTING TO NOMINAL PRESSURE. USED BALLOON FOR PRE-DILATION OF EXTERNAL ARTERY WHERE IT WAS MILDLY CALCIFIED. 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 DEVICE PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS 1:1. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THERE WAS NO RESISTANCE/FRICTION WITH OTHER DEVICES. THE BALLOON CATHETER WAS EASILY REMOVED. THE FOLLOWING INFORMATION WAS UNKNOWN: CONTRAST MEDIA USED; TYPE AND BRAND OF INFLATION DEVICE USED; IND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6513466 ↗