POWERFLEX 4400404SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20705032059142), received between Mar 27, 2019 and Dec 26, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 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. How this data works · Data updated Oct 13, 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 26, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 4MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED ON ITS FIRST INFLATION. A NON-CORDIS DEVICE WAS USED AS A REPLACEMENT, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS USED FOR PRE-DILATION AT THE EXTERNAL ILIAC ARTERY (EIA) WHICH HAD A CHRONIC TOTAL OCCLUSION (CTO). THE TARGET SITE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS WITH 100% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND AT ANY POINT DURING THE PROCEDURE AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED EASILY AND INTACT IN ONE PIECE FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898543 ↗
• MalfunctionMar 28, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES (ATM). AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT AND WAS INFLATED WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) LESION, A NON-CORDIS .035 GUIDEWIRE WAS INSERTED ACROSS THE LESION PRIOR TO THE USE OF THE POWERFLEX PRO PTA BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720648 ↗
• MalfunctionMay 23, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 4MM 4CM POWERFLEX PRO WAS BEING PREPPED BUT RUPTURED. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER POWER FLEX PRO (5*4) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988591 ↗
• MalfunctionJan 12, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE INITIAL INFLATION OF A 4MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON RUPTURED. THE DEVICE WAS REPLACED WITH A NEW POWERFLEX PRO PTA BALLOON CATHETER OF AN UNKNOWN SIZE, AND THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16152420 ↗
• MalfunctionMay 17, 2021Leak/Splash; Leak/Splash

  AS REPORTED, A 4MM X 4CM X 80CM POWER FLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS BEING INFLATED AT 18 ATMOSPHERES (ATM), BUT IT WAS CONFIRMED A LITTLE CONTRAST MEDIA LEAKED FROM THE DISTAL PART OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT CASE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11833175 ↗
• MalfunctionOct 23, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE BALLOON OF 4MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS INITIAL INFLATION. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS AT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO INFECTIOUS DISEASE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726604 ↗
• MalfunctionOct 15, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE POWERFLEX PRO BALLOON CATHETER RUPTURE WAS INSERTED AND INFLATED. HOWEVER IT RUPTURED APPROXIMATELY AT ITS RATED BALLOON PRESSURE DURING ITS INITIAL INFLATION. THERE WAS NO PATIENT INJURY. THE TARGET LESION IS THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD TORTUOSITY, SEVERELY CALCIFIED AND NINETY PERCENT STENOSIS. THERE WERE NO DIFFICULTY NOTED TO 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. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WAS DISCARDED IN THE HOSPITAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194647 ↗
• MalfunctionOct 2, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWER FLEX PRO (4MM4CM 80) WAS USED FOR THE ILIAC ARTERY WHICH HAD HEAVY CALCIFICATION. HOWEVER, IT RUPTURED AT 10 ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION. THE PROCEDURE WAS CONTINUED WITH ANOTHER NON-CORDIS BALLOON CATHETER AND A STENT WAS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9146250 ↗
• MalfunctionMay 6, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THIS WAS AN URGENT SHUNT CASE, A POWERFLEX PRO BALLOON WAS INFLATED AT TEN ATMOSPHERES, HOWEVER; IT RUPTURED. THERE WERE NO REPORTED PATIENT INJURIES. THE BALLOON WAS REPLACED WITH A NEW NON CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS STORED IN A WAREHOUSE IN THE HOSPITAL. 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. THE RE 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581916 ↗
• MalfunctionMar 27, 2019Material Frayed; Leak/Splash; Material Frayed; Leak/Splash

  DURING USE, THE POWERFLEX PRO BALLOON CATHETER WAS DELIVERED TO THE LESION AND UPON INFLATION THERE WAS A CONFIRMED THE LEAKAGE OF THE CONTRAST MEDIA. WHEN THE DEVICE WAS REMOVED, A "SPLIT" IN THE DEVICE WAS NOTICED. THERE WAS NO PATIENT INJURY. THEREFORE THE POWERFLEX BALLOON WAS REMOVED AND REPLACED WITH A NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WHICH HAD SEVERE CALCIFICATION. THE PHYSICIAN COMMENTED THAT THIS ISSUE MIGHT HAVE OCCURRED BY SEVERE CALCIFICATION. THE DEVICE WAS DISCARDED BY MISTAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8456897 ↗