POWERFLEX 4400802XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032059784), received between Nov 7, 2018 and Oct 15, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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.

• MalfunctionOct 15, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE RIGHT UPPER LOBE WAS DILATED, THE PRESSURE OF THE POWERFLEX PRO 8MM2CM 135 WAS BETWEEN 8-10ATM, BEFORE USE, THE FILLING LIQUID RATIO WAS NORMAL SALINE, AND THE FILLING SPEED WAS INJECTED SLOWLY. WHEN DILATED, THE LIQUID TURNED RED, SLIGHTLY PINK, TOOK THE BALLOON OUT THE BODY, FILLED THE BALLOON AGAIN AND FOUND THAT THE LIQUID WAS ALSO LIGHT RED, SUSPECTED OF RUPTURE OF THE BALLOON. THERE WERE NO REPORTED PATIENT INJURIES. THE CALCIFICATION OF THE LESION SITE WAS NOT OBVIOUS. THE DEVICE WAS STORED IN THE CATH LAB FOR ONE MONTH. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. 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. THE CONTRAST TO SALINE BRAND WAS 1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON CATHETER WAS REMOVED INTACT. THE TARGET LESION WAS THE RIGHT UPPER BRONCHUS. THERE WAS A SCAR WITH STENOSIS AND ULCERATIVE NECROSIS. THERE WAS NO VESSEL TORTUOSITY/ANGULATION. THERE WAS SIXTY PERCENT STE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9191995 ↗
• MalfunctionJun 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 135 8MM X 2CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INSERTED, HOWEVER, IT RUPTURED AT 10 ATMOSPHERES (ATM). THE DOCTOR FELT A LITTLE RESISTANCE ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE BALLOON CATHETER WAS REMOVED EASILY. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS REPLACED WITH A NEW POWERFLEX PRO BALLOON CATHETER AND WAS SUCCESSFULLY INFLATED. THE LESION WAS THE RIGHT EXTERNAL ILIAC ARTERY WITH STENOSIS. THE LESION HAD MODERATE CALCIFICATION. THERE WAS LITTLE VESSEL TORTUOSITY. THE PERCENTAGE STENOSIS WAS 90%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THE DEVICE DID PREP NORMALLY. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735433 ↗
• MalfunctionNov 7, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE POWERFLEX PRO BALLOON CATHETER WAS DELIVERED TO THE LESION AND WAS ATTEMPTED TO BE INFLATED. HOWEVER, THE BALLOON RUPTURED AT ITS NOMINAL PRESSURE DURING ITS INITIAL INFLATION. THERE WAS NO PATIENT INJURY. THEREFORE THE POWERFLEX BALLOON WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WHICH WAS SEVERELY CALCIFIED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8045763 ↗