POWERFLEX 4400504XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032059333), received between Jan 26, 2018 and Dec 2, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THE 5MM 4CMPOWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DEVICE RUPTURED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER POWERFLEX PRO BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE LESION WAS MINIMALLY CALCIFIED, AND THE VESSEL TORTUOSITY WAS ALSO MINIMAL. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. ADDITIONALLY, THERE WERE NO ISSUES ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE BALLOON CATHETER DID NOT KINK DURING USE, AND IT WAS REMOVED INTACT FROM THE PATIENT. IT WILL BE RETURNED FOR FURTHER ANALYSIS AND EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819067 ↗
• MalfunctionSep 26, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM 4CM POWERFLEX PRO WAS INFLATED AT THE ILIAC ARTERY LESION. HOWEVER, DURING THE INITIAL INFLATION, THE POWERFLEX PRO BALLOON RUPTURED AT 8 ATM. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER DEVICE (NON-CORDIS). THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR ANY OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE MILD CALCIFICATION WITH MILD VESSEL TORTUOSITY. THE LESION HAD A 90% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE INTO THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE DEVICE WAS NEVER IN AN ACUTE BEND AND WAS NOT KIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819396 ↗
• MalfunctionMay 22, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO 7MM 2CM WAS USED BUT IT RUPTURED WITHIN THE NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A PTA CASE. THE LESION WAS THE ILIAC REGION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16977376 ↗
• MalfunctionDec 2, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MM X 4CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED AS PRE-DILATION; BUT IT RUPTURED AT 6 ATMOSPHERES. THEREFORE, IT WAS REPLACED WITH ANOTHER UNKNOWN DEVICE AND THE PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD SEVERE CALCIFICATION. A CONTRALATERAL APPROACH WAS MADE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. AS OF NOTE, THIS COMPLAINT WAS REPORTED LATE BECAUSE IT WAS DIFFICULT FOR THE SALES REP TO MEET THE PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10934829 ↗
• InjuryAug 19, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 5MM X 4CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT COME BACK INTO A 6F NON-CORDIS SHEATH UPON REMOVAL. THE PHYSICIAN ATTEMPTED TO PULL THE SHEATH AND THE BALLOON OUT OF THE BODY TOGETHER, HOWEVER, THE DISTAL HALF OF THE BALLOON BECOME DISLODGED IN THE PATIENT¿S ARTERY. THE PHYSICIAN USED AN UNKNOWN STENT AND INFLATED THE BALLOON INTO THE INTIMAL WALL OF THE ARTERY. THERE WAS NO ADVERSE EFFECT ON THE PATIENT AND THE PATIENT WAS DISCHARGED NORMAL, WITH NO EXTENDED TIME OF OBSERVATION OR DELAY IN CARE. THIS WAS A PLANNED PTA/ATHERECTOMY/STENTING OF THE LEFT SUPERFICIAL ARTERY (SFA). A 6F NON-CORDIS SHEATH WAS USED AND DURING THE CASE, THE TIP BECAME DAMAGED. THE DEVICE WAS ATTEMPTED TO PTA THE ARTERY. THE PRODUCT WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD. 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. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10425454 ↗
• MalfunctionJan 26, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING THE USE OF THE POWER FLEX PRO, IT WAS REPORTED THAT THE BALLOON BURST WITHIN NOMINAL PRESSURE. THE PROCEDURE WAS STOPPED. THERE WAS NO PATIENT INJURY, THE TARGET LESION IS THE COMMON ILIAC ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7221293 ↗