POWERFLEX 4400502SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032059289), received between Nov 21, 2020 and Apr 24, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM 2CM POWERFLEX PRO RUPTURED BEFORE NOMINAL PRESSURE WAS REACHED. AFTER THAT, IT WAS EXPANDED WITH THE SAME SIZE BALLOON, AND THE PROCEDURE WAS COMPLETED BY SMART STENT PLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174247 ↗
• MalfunctionJul 24, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM 2CM POWERFLEX PRO RUPTURED WITHIN ITS NOMINAL PRESSURE AFTER THE NON-CORDIS GUIDEWIRE CROSSED THE ILIAC ARTERY LESION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PTA CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386306 ↗
• MalfunctionJun 2, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, 5MM X 2CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR PRE-DILATION, HOWEVER, IT RUPTURED AT 15 ATM FOR 30 SEC. PERFECT FOR DILATION OF THE LESION. SO, THE SMART STENT WAS IMPLANTED, AND POST-DILATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT EXTERNAL ILIAC ARTERY. AN APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED DUE TO HOSPITAL REGULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11923228 ↗
• MalfunctionNov 21, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 5MM X 2CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) BURST ON ITS FIRST INFLATION AT APPROXIMATELY 10 ATMS DURING INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER LABELLING. THE DEVICE WAS STORED, AND HANDLED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE LESION WAS MILDLY CALCIFIED AND TORTUOUS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. IT WAS 95 PERCENT STENOSED. NON CORDIS CONTRAST MEDIA WAS USED WITH A 50:50 CONTRAST TO SALINE RATIO. A NON CORDIS INDEFLATOR WAS USED, AND WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, NOT WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE DEVICE DID NOT HAVE TO PASS THROUGH A PREVIOUSLY PLACED STENT. NO UNUSUAL FORCE WAS USED DURING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10881503 ↗