POWERFLEX 4400404XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032059159), received between Jul 9, 2020 and Feb 14, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, THE 4MM 4CM POWERFLEX PRO BALLOON WAS NOT PACKAGED ASEPTICALLY. AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE PLASTIC ASEPTIC PACKAGE INSIDE WAS NOT SEALED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702401 ↗
• MalfunctionApr 20, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4 MM X 40 MM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER RUPTURED WHILE THE PRESSURE WAS RAISED TO INFLATE THE BALLOON; THEREFORE, IT COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY (PTA). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776119 ↗
• MalfunctionJan 12, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM X 4CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT NOMINAL PRESSURE ON THE FOURTH INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER OR WHEN REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50/50. A NON-CORDIS BRAND OF INDEFLATOR WAS USED.THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE LESION WAS NOT CALCIFIED AND HAD NO VESSEL TORTUOSITY. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE BALLOON INFLATED NORMALLY. THE BALLOON BURST AT NOMINAL PRESSURE. THE BALLOON-MAINTAINED PRESSURE DURING THE FIRST 3 INFALTIONS. THE BALLOON DID NOT SEEM TO ¿STICK¿ TO A STENT. THE BALLOON RE-WRAP PROPERLY. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED EASILY FROM THE VESSEL, SHEATH, RHV (ROTATING HEMOSTATIC VALVE, GUIDEWIRE AND GUIDE CATHETER. THE PRODUCT WAS REMOVED INTAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154711 ↗
• MalfunctionNov 19, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4MM X 4CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED; BUT IT RUPTURED AT 4 ATMOSPHERES (ATM). THEREFORE, IT WAS REPLACED WITH ANOTHER UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO PATIENT'S INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10868930 ↗
• MalfunctionJul 9, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO (4MM X 4CM X 135CM) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE USED, DELIVERED TO THE LESION AND INFLATED, HOWEVER, THEY RUPTURED WITHIN THEIR NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10250102 ↗