POWERFLEX 4400410XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032059210), received between Jan 13, 2021 and Jun 6, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, DURING AN INFLATION OF A 4MM X 10CM 135M POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, A PUNCTURE WAS OBSERVED ON THE DEVICE. AS A RESULT, AN UNKNOWN BALLOON CATHETER WAS USED IN PLACE OF THE 4MM X 10CM 135M POWERFLEX PRO PTA BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN ILIAC LESION WHICH WAS NOT REPORTED AS A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. AFTER THE PUNCTURE WAS OBSERVED, THE BALLOON CATHETER WAS ABLE TO BE REMOVED IN ONE PIECE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED, AND THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601623 ↗
• MalfunctionApr 7, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM X 10CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING PREPARATION OF THE DEVICE AND WAS UNABLE TO BE INFLATED. AS A RESULT, A 6MM X 80MM CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE IN WHICH THE POWERFLEX PRO PTA BALLOON CATHETER WAS TO BE USED ON A CALCIFIED AND TORTUOUS LESION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. ADDITIONALLY, THE BALLOON REMAINED IN ONE PIECE AFTER THE RUPTURE OCCURRED. FURTHER INFORMATION REGARDING WHICH CORDIS BALLOON COMPLETED THE PROCEDURE, CONTRAST MEDIA USED, CONTRAST TO SALINE RATIO, INFLATION DEVICE USED, TARGET LESION, AND PERCENTAGE OF STENOSIS/PRESENCE OF A CHRONIC TOTAL OCCLUSION (CTO) WAS REQUESTED BUT NOT PROVIDED, AND THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043824 ↗
• MalfunctionJan 13, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM X 10CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT ITS NOMINAL PRESSURE OF 10 ATMOSPHERES (ATM), DURING IT'S SECOND INFLATION. ANOTHER POWERFLEX PRO WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, 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 DEVICE PREPPED NORMALLY. A NON CORDIS INDEFLATOR WAS USED WITH 50/50 CONTRAST TO SALINE RATIO. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE NOR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. NO UNUSUAL FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11164658 ↗