POWERFLEX 4400808XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032059869), received between Dec 18, 2017 and Jun 29, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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.

• InjuryJun 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE CONNECTION BETWEEN THE DISTAL TIP AND THE BALLOON 8MM 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON FRACTURED INSIDE OF THE PATIENT DURING USE. A SNARE WAS USED TO REMOVE THE SEPARATED PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER POWERFLEX PRO DEVICE. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE 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 DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE TARGET LESION WAS AN ARTERIOSCLEROSIS OF THE LOWER LIMBS. DELUSION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL HAD MODERATE TORTUOSITY. THE LESION HAD A 70% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON CATHETER DID HAVE A MILD KINK WHILE BEING USED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19640606 ↗
• MalfunctionDec 16, 2021Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, AFTER THE POWERFLEX PRO 8MM8CM 135 BALLOON CATHETER WAS REMOVED FROM THE PACKAGING, IT WAS FOUND THAT THE DELIVERY SYSTEM AT THE HEAD-END OF THE BALLOON WAS SERIOUSLY KINKED AND SPLIT BUT NOT YET SEPARATED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A LIMB ARTERY BALLOON ANGIOPLASTY. THE LESION WAS MODERATELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 70%. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE PRODUCT WAS RECEIVED IN THIS CONDITION. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO DAMAGE NOTED TO THE BOX, POUCH OR HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN BALLOON. THE PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017900 ↗
• MalfunctionDec 18, 2017Burst Container or Vessel; Difficult To Position; Difficult to Advance; Burst Container or Vessel; Difficult To Position; Difficult to Advance

  DURING PRE DILATION, IT WAS REPORTED THAT THE POWERFLEX BALLOON CATHETER RUPTURED; ADDITIONAL INFORMATION WAS RECEIVED AND THERE WAS DIFFICULTY INFLATING THE POWER FLEX BALLOON DURING PREP, ADVANCING THE BALLOON CATHETER THROUGH THE LESION AND CROSSING THE LESION. THERE WAS NO PATIENT INJURY. THE POWERFLEX WAS REMOVED FROM THE PATIENT AND A NON CORDIS BALLOON CATHETER WAS INSERTED. A SMART STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PREOPERATIVE COMPUTED TOMOGRAPHY (CT) SHOWED THE LEFT ILIAC VEIN WAS OCCLUSION. WHILE IN A SEVERE LONG PRONE POSITION, UNDER THE GUIDANCE OF ULTRASOUND, A NON CORDIS GUIDEWIRE WAS INSERTED FROM THE POPLITEAL VEIN PUNCTURE IN SUPERFICIAL FEMORAL VEIN AND THROUGH THE COMMON FEMORAL VEIN. AFTER ANGIOGRAPHY, THE TRUNK OF ILIAC VEIN DISAPPEARED AND THE BRANCHES DEVELOPED. THEN THE GUIDE WAS REMOVED AND ANOTHER NON CORDIS 4F GUIDEWIRE WITH AN UNKNOWN 4F CATHETER WAS INSERTED. THE DEVICE CROSS THE LESION AND ARRIVED AT THE INFERIOR VENA CAVA WHICH WAS CONFIRMED BY ANGIOGRAPHY. A NON CORDIS BALLOON CATHETER (6*8) WAS USED TO PREP-EXPAND AND THEN USED THE POWERFLEX PRO BALLOON. AFTER THE BALLOON ENTERED THE PATIENT'S BODY, THE PUMP PRES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125798 ↗