POWERFLEX 4400415XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032059258), received between May 13, 2020 and Aug 5, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM X 15CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING THE PROCEDURE. THE DEVICE WAS NOT AVAILABLE AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PTA PROCEDURE. THE TARGET VESSEL WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED MILD TORTUOSITY AND 70% STENOSIS WITH NO SIGNS OF CALCIFICATION. THE DEVICE WAS STORED, PREPARED, AND USED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DAMAGE TO THE DEVICE OR DEVICE PACKAGING PRIOR TO USE. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF THE POWERFLEX PRO BALLOON CATHETER AND HAS USED THE DEVICE SEVERAL TIMES PRIOR TO THIS PROCEDURE. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO USED WAS 1:1. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715790 ↗
• MalfunctionJan 15, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THE 4MM X 15CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) COULD NOT BE FILLED AND IT'S RUPTURED.. THE USER WAS ABLE TO DEPRESS THE PLUNGER INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THE BALLOON DID NOT INFLATE NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS 3ATMS. THE BALLOON DID NOT MAINTAIN PRESSURE DURING INFLATION. PRESSURE WAS NOT MAINTAINED: THE BALLOON DID NOT BURST AND NEITHER DID THE SHAFT. THE BALLOON DID NOT SEEM TO ¿STICK¿ TO A STENT. THE BALLOON DID NOT DEFLATE OR RE-WRAP PROPERLY, AND THE BALLOON CATHETER WAS REMOVED WITH GREATER EFFORT. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED EASILY: FROM THE VESSEL, GUIDEWIRE BUT WAS NOT REMOVED EASILY FROM THE SHEATH OR ROTATING HEMOSTATIC VALVE. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. ANOTHER BALLOON WAS USED FOR PRE-DILATION. IT WAS NOTED , WHEN AN INFLATION DEVICE WAS ATTACHED TO THE INFLATION LUMEN PORT OF THE DEVICE. REQUIRED PRESSURE WAS APPLIED TO THE DEVICE TO INFLATE THE BALLOON, WITHOUT SUCCESS. THE BALLOON COULDN¿T BE INFLATED. ALSO, THE BALLOON WAS OBSERVED INTACT THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11176570 ↗
• MalfunctionDec 17, 2020Leak/Splash; Leak/Splash

  DURING AN INTERVENTIONAL PROCEDURE, WHEN A 10MM X 4CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER REACHED THE LESION AND PRESSURE PUMP WAS PRESSURIZED; THE BALLOON WAS FOUND TO HAVE LEAKED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER BALLOON AND THERE WAS NO PATIENT INJURY. THE INDICATION FOR PROCEDURE WAS FOR OPENING OF THE LEFT LOWER LIMBS ARTERY OCCLUSION. THE 80% OCCLUDED LESION WAS MODERATELY CALCIFIED WITH NO VESSEL TORTUOSITY. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE CONTRAST TO SALINE RATIO WAS 1:1. A MERIT INFLATION DEVICE WAS USED AND IT 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. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON COULD NOT BE INFLATED AT ALL AND DID NOT KINK WHILE BEIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11029359 ↗
• MalfunctionMay 13, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE 4MM X15CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS PRE-EXPANDED IN THE PATIENT¿S BODY HOWEVER IT COULD NOT BE FILLED, AND IT WAS FOUND THAT THERE WAS AIR LEAKAGE IN THE BALLOON AFTER WITHDRAWING IT FROM THE PATIENT¿S BODY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10052275 ↗