POWERFLEX 4400904XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032059944), received between Jul 7, 2021 and Jul 29, 2021 — 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.

• MalfunctionJul 29, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 9MM X 4CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT IT RUPTURED DUE TO SEVERE CALCIFICATION. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BALLOON CATHETER WAS REMOVED EASILY AND INTACT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED BY MISTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245149 ↗
• MalfunctionJul 13, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 9MM X 4CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED. HOWEVER, THERE WAS DIFFICULTY CROSSING THE LESION AND THE BALLOON RUPTURED DUE TO SEVERE CALCIFICATION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS REMOVED AND ANOTHER UNKNOWN DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE TARGET LESION IS THE ILIAC ARTERY. THE DEVICE WAS NOT USED IN A CHRONIC TOTAL OCCLUSION CASE WITHIN THREE MONTHS. THERE WERE NO DIFFICULTY NOTED IN THE BALLOON 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. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WERE USED. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE VESSEL. THERE WAS DIFFICULTY CROSSING THE LESION. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PLUNGER WAS DEPRESS INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED BY MISTAKE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162216 ↗
• MalfunctionJul 7, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 9MM X 4CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED, BUT IT RUPTURED DUE TO SEVERE CALCIFICATION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN THE STERILE FIELD. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS USED FOR AN ENDOVASCULAR THERAPY (EVT) CASE. THE TARGET LESION WAS THE ILIAC ARTERY. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY A MISTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12126777 ↗