POWERFLEX 4400304XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032058992), received between Jul 5, 2017 and Jul 21, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2023Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 3MM X 4CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS LEAKING WHEN TESTED DURING PREPARATION. POSITIVE PRESSURE WAS BEING APPLIED TO THE BALLOON WHEN THE LEAKAGE OCCURRED. AS A RESULT, A NON-CORDIS DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON WAS PREPPED WITH A 1:1 CONTRAST TO SALINE RATIO AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374864 ↗
• MalfunctionJun 23, 2023Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 3MM X 4CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS LEAKING AND COULD NOT BE FILLED. AS A RESULT, A NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS BEING USED FOR A URETERAL DILATION WHEN THE LEAKAGE OCCURRED. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE BALLOON WAS PREPPED WITH A 1:1 CONTRAST TO SALINE RATIO. THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192568 ↗
• MalfunctionJul 5, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING THE TIME OF THE TIBIAL ARTERY, THE POWER FLEX PRO BALLOON BURST AND ALMOST TORE OFF. THE DOCTOR COULD STILL PULL THE BALLOON OUT OF THE PATIENT. THE DEVICE WAS REPLACED WITH AN UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT INJURY. THE DEVICE PREP NORMALLY. 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. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE CONTRAST MEDIA USED IS ACCUPAQUE 300, GE WITH A CONTRAST TO SALINE RATIO WAS 1:3. THE TYPE AND BRAND OF INFLATION DEVICE USED WAS ENCORE 26, BOSTON SCIENTIFIC. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER, OR THE VESSEL. THERE WERE NO DIFFICULTY CROSSING THE LESION. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6685785 ↗