POWERFLEX 4400510XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032059395), received between Jul 18, 2017 and Jan 7, 2022 — 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.

• MalfunctionJan 7, 2022Burst Container or Vessel; Burst Container or Vessel

  DURING USE IN THE PATIENT, THE BALLOON OF THE POWERFLEX PRO BALLOON CATHETER RUPTURED AT FIFTEEN ATMOSPHERE (15ATM). THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR ANALYSIS. THE DEVICE WAS CHANGED TO ANOTHER UNKNOWN BALLOON TO COMPLETE THE PROCEDURE. THE TARGET LESION IS THE SUPERFICIAL FEMORAL ARTERY WHICH WAS MODERATELY CALCIFIED AND STENOSED EIGHTY PERCENT (80%). 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. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WERE USED. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER, OR THROUGH THE VESSEL. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13197360 ↗
• MalfunctionJul 18, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A POWER FLEX PRO BALLOON CATHETER RUPTURED. THEREFORE THE POWER FLEX WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ¿EVT¿ CASE. A POWER FLEX PRO WAS INSERTED FOR INFLATION, HOWEVER IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE PREP NORMALLY. 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 PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6721426 ↗