POWERFLEX 4400604SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20705032059517), received between Dec 18, 2017 and Dec 1, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2023Deflation Problem; Deflation Problem

  AS REPORTED, THE INFLATION OF A 6MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS REMARKABLY SLOW. AS A RESULT, THE DEVICE WAS DEFLATED AND REMOVED; HOWEVER, THE DEFLATION OF THE DEVICE WAS REMARKABLY SLOW AS WELL. THE DEVICE WAS REPLACED WITH A 6MM X 4CM SABERX PTA BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AND ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT A 90% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH HAD MILD CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A NON-CORDIS GUIDEWIRE WAS USED, AND THE POWERFLEX PRO PTA BALLOON CATHETER WAS ADVANCED ALONG THE NON-CORDIS GUIDEWIRE PRIOR TO ITS ATTEMPTED INFLATION. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM) VIA AN UNKNOWN INFLATION DEVICE AND WAS ABLE TO BE FULLY DEFLATED PRIOR TO ITS REMOVAL. THE DEVICE REMAINED IN ONE PIECE DURING ITS REMOVAL FROM THE PATIENT. THE DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245234 ↗
• MalfunctionDec 13, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A POWERFLEX PRO 6MM 4CM 80 RUPTURED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE LESION TO BE TREATED WAS IN THE ILIAC ARTERY. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984470 ↗
• MalfunctionOct 28, 2021Leak/Splash; Leak/Splash

  AS REPORTED, WHEN THE SURGEON WAS ATTEMPTING TO USE A POWERFLEXPRO 6MM 4CM BALLOON CATHETER TO EXPAND THE NARROWED BLOOD VESSEL/LESION, IT WAS FOUND THAT THE BALLOON COULD NOT BE FILLED DUE TO A LEAK FROM THE MIDDLE SECTION OF THE BALLOON. THE DAMAGE WAS FOUND AFTER THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, AND NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR ANY OTHER DAMAGES NOTED ON THE DEVICE PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS IN THE BASILIC VEIN. THE LESION WAS NOTED TO HAVE A 100% STENOSIS. THE INFLATION DEVICE WAS FILLED WITH A SALINE/CONTRAST RATIO OF 1:1. THAT SAME INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES DURING THE PROCEDURE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE THE BALLOON CATHETER WAS INSERTED INTO THE ROTATING HEMOSTATIC VALVE. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712656 ↗
• MalfunctionAug 10, 2021Leak/Splash; Leak/Splash

  AS REPORTED, THE 6MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS ADVANCED OVER THE WIRE (UNKNOWN) INTO THE PATIENT; HOWEVER, WHEN INFLATION WAS ATTEMPTED, THE BALLOON WOULDN'T INFLATE. WHEN THE BALLOON WAS TAKEN OUT, IT APPEARED THAT THERE WAS A SMALL HOLE IN THE BALLOON AND THE BALLOON LEAKED OUT CONTRAST. ANOTHER CORDIS BALLOON WAS USED TO COMPLETE THE PROCEDURE AND THE OUTCOME WAS GOOD. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS A TRAINED POWERFLEX PRO USER. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. A PERIPHERAL ANGIOGRAPHY WAS BEING PERFORMED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE FORMING TUBE. NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE APPEARED TO PREP NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE LESION WAS SLIGHTLY CALCIFIED WITH NO VESSEL TORTUOSITY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301647 ↗
• MalfunctionMay 25, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS INSERTED AND WAS INFLATED; BUT IT RUPTURED AT 10 ATMOSPHERIC PRESSURE (ATM) DURING ITS INITIAL INFLATION. THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER (6MM*4CM, NON-CORDIS) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT COMMON FEMORAL ARTERY. THE LESION HAD SEVERE CALCIFICATION AND STENOSIS. A CONTRALATERAL APPROACH WAS MADE WITH A SHEATH (6F, NON-CORDIS). A GUIDEWIRE (NON-CORDIS) WAS INSERTED AND CROSSED THE LESION AND AN INTRAVASCULAR ULTRASOUND (IVUS) CHECKED THE LESION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED IN THE HOSPITAL. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11878187 ↗
• MalfunctionOct 6, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT IT RUPTURED AT 4 ATMOSPHERIC PRESSURE (ATM). IT WAS REPLACED WITH ANOTHER DEVICE (UNKNOWN) AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT LOOKED NORMAL WHEN IT WAS REMOVED FROM ITS PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE PREPPED NORMALLY. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638191 ↗
• MalfunctionMar 16, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM X 4CM X 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED ON ITS SECOND INFLATION. THEREFORE, IT WAS REPLACED WITH A NEW POWER FLEX PRO. AFTER THAT A SMART STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED AS A PRE DILATION. THE LESION WAS THE ILIAC ARTERY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE LESION WAS SEVERELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 90%. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP/ PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY (MAINTAIN NEGATIVE PRESSURE). THE CONTRAST TO SALINE RATIO WAS 50:50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE/GUIDE CATHETER. THERE WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835715 ↗
• MalfunctionJun 18, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THIS WAS AN ENDOVASCULAR TREATMENT (EVT) CASE, A POWERFLEX PRO 6MM4CM 80 RUPTURED DURING ITS INITIAL INFLATION. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE LESION WAS THE ILIAC ARTERY. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8709261 ↗
• MalfunctionMar 28, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE POWER FLEX PRO RUPTURED AT FOUR ATMOSPHERE. THERE WAS NO PATIENT INJURY. THE POWER FLEX PRO WAS REPLACED WITH A NON CORDIS BALLOON CATHETER AND POST DILATION WAS COMPLETED. AFTER THE STENT WAS IMPLANTED, A POWER FLEX PRO WAS DELIVERED FOR A POST DILATATION. THE LESION IS THE ILIAC ARTERY WHICH WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND WITH NINETY PERCENT STENOSIS. THE BALLOON WAS DELIVERED TO A PART THAT WAS NOT DILATED ENOUGH. HOWEVER THE BALLOON RUPTURED. THERE WAS NO ANOMALIES CONFIRMED DURING THE PROCEDURE. THERE WERE NO DIFFICULTY INFLATING 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. 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 WAS USED. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER, OR THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER HAS NEVER BEEN IN AN ACU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7377765 ↗
• MalfunctionDec 18, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING A LERICHE SYNDROME BALLOON KISSING CASE, IT WAS REPORTED THAT THE POWERFLEX BALLOON CATHETER RUPTURED AT ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. IT IS UNKNOWN HOW THE PROCEDURE COMPLETED, HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS 100 % (CTO). THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125476 ↗