POWERFLEX 4400515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032059432), received between Jun 5, 2017 and Oct 2, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING THE PTA PROCEDURE, THE BALLOON OF A 5MM X 15CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST WHEN INFLATED WITH NORMAL AIR PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10619598 ↗
• MalfunctionJun 5, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT FIVE (5) POWERFLEX PRO BALLOON CATHETER (BC) BURST AT TEN TO TWELVE ATMOSPHERE (10-12 ATM) DURING THE INTERVENTION IN THE SAME PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICE WAS PREP NORMALLY. THERE WERE NO DIFFICULTY INFLATING THE BALLOONS DURING PREP. 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 REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. CONTRAST MEDIA USED WAS SOLUTRAST 350. THE CONTRAST TO SALINE RATIO WAS CM+NACL. THE TYPE AND BRAND OF INFLATION DEVICE USED WAS ARCROYAL WHICH WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, GUIDE CATHETER, AND THROUGH THE VESSEL. THERE WERE NO DIFFICULTY CROSSING THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6610570 ↗
• MalfunctionJun 5, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT FIVE (5) POWERFLEX PRO BALLOON CATHETER (BC) BURST AT TEN TO TWELVE ATMOSPHERE (10-12 ATM) DURING THE INTERVENTION IN THE SAME PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICE WAS PREP NORMALLY. THERE WERE NO DIFFICULTY INFLATING THE BALLOONS DURING PREP. 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 REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. CONTRAST MEDIA USED WAS SOLUTRAST 350. THE CONTRAST TO SALINE RATIO WAS CM+NACL. THE TYPE AND BRAND OF INFLATION DEVICE USED WAS ARCROYAL WHICH WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, GUIDE CATHETER, AND THROUGH THE VESSEL. THERE WERE NO DIFFICULTY CROSSING THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6610540 ↗