POWERFLEX 4401010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032060124), received between Mar 18, 2021 and Apr 13, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A POWERFLEX PRO 10MM 10CM 135 BURST BEFORE REACHING THE RATED WORKING/BURST PRESSURE, BELOW THE RBP. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT (IN ONE PIECE). THE CASE WAS COMPLETED WITH A NON-CORDIS BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR ANY OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPER NORMALLY. THE BALLOON RUPTURED WHILE IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE BALLOON WAS NOT IN A STENT WHEN IT RUPTURED. THE LESION WAS NOTED TO HAVE PLAQUE AND STENOSIS. THE LESION HAD MODERATE CALCIFICATION WITH A 35% STENOSIS. THE DEVICE WAS BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE MANUAL PRESSURE PUMP WAS FILLED WITH A SALINE/CONTRAST RATIO OF 1:1. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING THE CASE. THERE WAS NO RESISTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106971 ↗
• MalfunctionMar 18, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN A 10MM X 10CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER PASSED THROUGH THE LESION; FOUND THAT THE BALLOON WAS RUPTURED WHEN INFLATED TO THE NORMAL WORKING PRESSURE, SO IT FAILED TO EXPAND. THE BALLOON DID NOT REWRAP PROPERLY BUT WAS REMOVED EASILY. THE PROCEDURE WAS COMPLETED USING ANOTHER UNKNOWN BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN THE STERILE FIELD. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE USER WAS SKILLED WITH THE DEVICE AND PROCEDURE. THE INTENDED PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF AN UNKNOWN LOWER EXTREMITY VESSEL. THE VESSEL HAD NO CALCIFICATION, NO TORTUOSITY, 70% STENOSIS, AND WAS NOT A CTO. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING 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 DEVICE PREPPED NORMALLY. THE DEVICE WAS PREPPED WITH A 2:3 CONTRAST TO SALINE RATIO WITH UNKNOWN CONTRAST. THE BALLOON WAS INFLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11511815 ↗