POWERFLEX 4400610SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032059579), received between Aug 2, 2019 and Mar 22, 2022 — classified as 1 injury, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A POWERFLEX PRO 6MM 10CM RUPTURED WITHIN NOMINAL PRESSURE DURING THE SECOND INFLATION ATTEMPT. THE POWERFLEX WAS INFLATED WITHIN ITS NOMINAL PRESSURE DURING THE INITIAL INFLATION. IT WAS REMOVED AND ANGIOGRAPHY WAS DONE AGAIN. IT SHOWED THE LEFT EXTERNAL ILIAC ARTERY WHICH WAS BEING TREATED RUPTURED. A NON-CORDIS STENT WAS IMPLANTED. A NON-CORDIS BALLOON CATHETER WAS USED FOR LONG-INFLATION AND HEMOSTASIS WAS ACHIEVED. AN IPSILATERAL APPROACH WAS MADE WITH A NON-CORDIS SHEATH. THE UNKNOWN GUIDEWIRE CROSSED THE LESION. THERE WAS NO CALCIFICATION. ON THE FOLLOWING DAY, THERE WAS OCCLUSION AND RETREATMENT WAS DONE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION COULD NOT BE OBTAINED.

  Patient problems: Obstruction/Occlusion; Rupture

  MAUDE report 13847334 ↗
• MalfunctionMar 17, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A POWERFLEX PRO 6MM 10CM 80 RUPTURED AT 8ATM; THEREFORE THE CASE WAS COMPLETED WITH A NEW POWERFLEX 6X40 BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS IN THE RIGHT COMMON ILIAC ARTERY WHICH HAD A CHRONIC TOTAL OCCLUSION (CTO). A UNKNOWN .035 GUIDEWIRE CROSSED THE LESION. A POWERFLEX PRO 4X100 WAS USED FOR PRE-DILATION OF THE VESSEL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13793776 ↗
• MalfunctionSep 24, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM X 15CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT IT RUPTURED AT 12 ATMOSPHERIC PRESSURE (ATM) DURING ITS SECOND INFLATION. THEREFORE, ANOTHER POWERFLEX PRO (6MM X 10CM X 80CM) WAS USED BUT IT RUPTURED AT 10 ATM DURING ITS INITIAL INFLATION. A NEW 6MM BALLOON CATHETER (NON-CORDIS) WAS USED AND IT INFLATED AT THE LESION. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY WHICH HAD SEVERE CALCIFICATION AND CONTINUOUS STENOSIS. AN IPSILATERAL APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A NON-CORDIS SHEATH (6F 26CM). A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE GUIDEWIRE WAS REPLACED WITH ANOTHER NON-CORDIS GUIDEWIRE. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS DEVICES WERE DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10579521 ↗
• MalfunctionDec 3, 2019Defective Component; Defective Component

  AS REPORTED, THE INTERNAL LIGHT OF THE 6MM X 10CM X 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS ALTERED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401228 ↗
• MalfunctionAug 2, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE POWERFLEX PRO BALLOON CATHETER RUPTURED AT TEN ATMOSPHERE (10 ATM) DURING ITS INITIAL INFLATION. THERE WAS NO PATIENT INJURY. THEREFORE THE BALLOON WAS REPLACED WITH A NEW COMPETITOR'S BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION SEEMED TO BE HEAVILY CALCIFIED. THE RATE OF STENOSIS WAS HIGH. AN IPSILATERAL APPROACH WAS MADE WITH A 6F COMPETITOR'S GUIDING SHEATH. A COMPETITOR'S 0.035 GUIDEWIRE CROSSED THE LESION AND A POWERFLEX PRO WAS DELIVER TO THE LESION FOR PRE DILATION. HOWEVER IT RUPTURED AT 10 ATM DURING ITS INITIAL INFLATION. THE DEVICE HAS BEEN DISCARDED IN THE HOSPITAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8855995 ↗