POWERFLEX 4400804XRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20705032059821), received between Dec 6, 2016 and Jul 1, 2022 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO 7MM 4CM WAS USED; HOWEVER, THE BALLOON RUPTURES AT 8ATM (BELOW RBP). THE CASE WAS COMPLETED AFTER AN UNKNOWN 6MM BALLOON WAS USED, WHICH WAS USED IN ANOTHER LESION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS IN THE ILIAC. THE DEVICE 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, 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 WAS PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL HAD MILD TORTUOSITY. THE LESION WAS NOTED TO HAVE A 90% STENOSIS; HOWEVER, THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE BALLOON DID NOT RUPTURE WHILE IN A STENT. THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THE BALLOON CATHETER ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY. THERE WAS NO DIFFICULTY C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888172 ↗
• MalfunctionJun 24, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 4CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING ITS NOMINAL PRESSURE DURING PRE-DILATION OF THE ILIAC ARTERY. AS A RESULT, THE 6MM X 4CM 135CM POWERFLEX PRO PTA BALLOON CATHETER WAS REPLACED BY A NON-CORDIS BALLOON CATHETER OF THE SAME SIZE. THIS WAS FOLLOWED BY THE IMPLANTATION OF A S.M.A.R.T. SELF-EXPANDING STENT (SES). AFTER STENT IMPLANTATION, AN 8MM X 4CM 135CM POWERFLEX PRO PTA BALLOON CATHETER WAS TO BE USED FOR POST-DILATION WHEN THE BALLOON RUPTURED BEFORE REACHING ITS NOMINAL PRESSURE. THE 8MM X 4CM 135CM PTA BALLOON CATHETER WAS REPLACED BY A SECOND NON-CORDIS BALLOON CATHETER WHICH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. AN APPROACH WAS MADE FROM THE LEFT UPPER EXTREMITY FOR THIS PROCEDURE. BOTH OF THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800159 ↗
• MalfunctionApr 22, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE INTEGRITY OF THE BALLOON ON A 8MM X 4CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND TO BE COMPROMISED/PUNCTURED. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14185743 ↗
• MalfunctionApr 12, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 4CM 80CM POWERFLEX PRO .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION TO NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT AN ILIAC LESION. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT AND THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED DURING INSERTION. THE DEVICE WAS ABLE TO TRACK TOWARDS THE LESION WITH EASE; HOWEVER, THERE WAS DIFFICULTY CROSSING THE LESION AND THE DEVICE WAS PUT INTO AN ACUTE BEND. THE BALLOON CATHETER WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING REMOVAL. INFORMATION REGARDING THE PATIENT, TARGET VESSEL CHARACTERISTICS, CONTRAST USED, CONTRAST TO SALINE RATIO, POSSIBLE KINKING OF THE DEVICE, AND THE COMPLETION OF THE PROCEDURE WAS REQUESTED BUT NOT PROV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088180 ↗
• MalfunctionApr 4, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO POWERFLEX PRO 8MM 4CM 135 RUPTURED AT APPROX 5 ATMS WHILE INFLATING IN THE LEFT COMMON ILIAC ARTERY. THE CASE WAS COMPLETED WITH A NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE BALLOONS WERE STORED AND USED PER IFU AND UNDER STERILE TECHNIQUE. THE DEVICE WAS PREPPER PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE LESION HAD A 55-65% STENOSIS AS THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION. THE LESION WAS MODERATELY CALCIFIED AND NON-TORTUOUS. THE NON-CORDIS INFLATION DEVICE WAS FILLED WITH 40/60 CONTRAST/SALINE RATIO. ISOVUE 300 WAS USED TO FILL THE INFLATION DEVICE. THE INFLATION DEVICE USED WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996258 ↗
• MalfunctionMar 26, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO POWERFLEX PRO 8MM 4CM 135 RUPTURED AT APPROX 5 ATMS WHILE INFLATING IN THE LEFT COMMON ILIAC ARTERY. THE CASE WAS COMPLETED WITH A NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE BALLOONS WERE STORED AND USED PER IFU AND UNDER STERILE TECHNIQUE. THE DEVICE WAS PREPPER PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE LESION HAD A 55-65% STENOSIS AS THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION. THE LESION WAS MODERATELY CALCIFIED AND NON-TORTUOUS. THE NON-CORDIS INFLATION DEVICE WAS FILLED WITH 40/60 CONTRAST/SALINE RATIO. ISOVUE 300 WAS USED TO FILL THE INFLATION DEVICE. THE INFLATION DEVICE USED WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13914637 ↗
• MalfunctionSep 20, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MM X 4CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT IT RUPTURED IN THE MID BALLOON SEGMENT BEFORE THE PRESSURE REACHED ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND/OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR ANY OTHER DAMAGES WERE NOTED ON THE DEVICE PRIOR TO INSERTING IN THE PATIENT. THE DEVICE WAS PREPPED PROPERLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED LESION WAS IN THE ILIAC ARTERY. THE LESION HAD MODERATE CALCIFICATION. THE DEVICE WAS BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE VESSEL HAD TORTUOSITY WITH AN ACUTE BEND. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. NO RESISTANCE WAS NOTED WHILE ADVANCING THROUGH THE GUIDE CATHETER. THE BALLOON CATHETER WAS ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY. SOME DIFFICULTY WAS NOTED WHILE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500424 ↗
• MalfunctionSep 16, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 8MM X 4CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED; HOWEVER, IT RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS SEVERELY CALCIFIED. THERE VESSEL HAD SEVERE TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 90%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE 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 WAS PREPPED NORMALLY (I.E., MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PLUNGER WAS DEPRESSED INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. LEAKAGE WAS CONFIRMED FROM THE BALLOON. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479471 ↗
• MalfunctionSep 2, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MM X 4CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT IT RUPTURED, AND IT WAS NOT ABLE TO BE INFLATED. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) CASE. THE LESION HAD LITTLE CALCIFICATION. THERE WAS LITTLE VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 99%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE 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 WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12412036 ↗
• MalfunctionMay 27, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING THE INITIAL INFLATION, AN 8MM X 4CM X 135 CM POWERFLEX PRO WAS INFLATED AT 8 ATMOSPHERE (ATM) FOR 5 MINUTES, BUT WAS SLIGHTLY UNDER-INFLATED, SO, IT WAS ATTEMPTED TO BE INFLATED AT SECOND INFLATION AT 12 ATM FOR 3 MINUTES. HOWEVER, IT RUPTURED IN ABOUT 1 MINUTE. SINCE THE LUMEN WAS SECURED TO SOME EXTENT, AN UNKNOWN STENT WAS IMPLANTED. AFTER THAT, AN UNKNOWN BALLOON CATHETER WAS USED TO PERFORM POST DILATION. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE LEFT COMMON ILIAC ARTERY TO EXTERNAL ILIAC ARTERY. AN APPROACH WAS MADE FROM THE LEFT BRACHIAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093950 ↗
• MalfunctionJan 10, 2020Leak/Splash; Leak/Splash

  THE USER WAS ABLE TO DEPRESS THE PLUNGER INTO THE INDEFLATOR WHEN TRYING TO INFLATE THE BALLOON OF THE 8MM X 4CM X 135CM POWERFLEX PRO PTA BALLOON CATHETER (BC) HOWEVER IT DID NOT INFLATE NORMALLY DURING THE PROCEDURE AND PROBABLY WAS PUNCTURED. LEAKAGE WAS NOTED FROM THE BALLOON. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USED OF ANOTHER CORDIS BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS ILIAC ANGIOPLASTY. THE TARGET LESION WAS THE ILIAC ARTERY. THE 60% OCCLUDED LESION HAD A MODERATE CALCIFICATION. THERE WAS NO VESSEL TORTUOSITY AND THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE PRODUCT WAS INTACT AND WAS PREP NORMALLY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED DURING USE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9576553 ↗
• InjuryAug 5, 2019Burst Container or Vessel; Activation, Positioning or Separation Problem; Burst Container or Vessel; Activation, Positioning or Separation Problem

  AS REPORTED, THE PHYSICIAN USED A POWERFLEX PRO PTA BALLOON CATHETER (8 X 40 MM X 135 CM). THE PHYSICIAN TOOK THE BALLOON PAST RATED BURST (12) TO 15- ATMOSPHERES PRESSURE (ATM). THE BALLOON SHATTERED INSIDE THE PATIENT WHICH THEY NEEDED TO SNARE OUT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 8862034 ↗
• InjuryDec 6, 2016Burst Container or Vessel; Detachment Of Device Component; Burst Container or Vessel; Detachment Of Device Component

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE POWERFLEX PRO 8MM4CM 135 BALLOON BURST AND A PIECE OF THE BALLOON WAS NOT RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6147314 ↗