POWERFLEX 4400702SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032059654), received between Jul 24, 2019 and Mar 31, 2021 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2021Burst Container or Vessel; Burst Container or Vessel

  WHEN A 7MM X 2CM 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INSERTED, IT WAS ATTEMPTED TO BE INFLATED AT 10 ATMOSPHERES (ATM); HOWEVER, IT RUPTURED. IT WAS THEN REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND ANOTHER HIGH PRESSURE NON-CORDIS BALLOON CATHETER WAS ALSO PLACED. A SMART CONTROL STENT WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE COMMON ILIAC ARTERY. THE LESION HAD SEVERE CALCIFICATION AND STENOSIS. AN IPSILATERAL APPROACH WAS MADE WITH A 6F NON-CORDIS SHEATH AND A NON-CORDIS GUIDEWIRE CROSSED THE LESION. AN INTRAVASCULAR ULTRASOUND (IVUS) CHECKED THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED IN THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11598165 ↗
• InjurySep 4, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  DURING THE OPERATION, THE BALLOON OF A 7MM X 2CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER EXPLODED INSIDE THE PATIENT WHEN THE DOCTOR TRIED TO INFLATE IT AND THE DEVICE WAS REMOVED IN 2 PIECES. THE EVENT CAUSED AN INCREASE IN PROCEDURE DURATION OF 60 MINUTES. THE EVENT CAUSED A 24 HOUR HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION. NO OTHER PATIENT INJURY REPORTED. THE PRODUCT WAS STORED AS PER LABELING. THE DEVICE WAS OPENED IN A STERILE FIELD. THE LESION WAS NOT CALCIFIED NOR TORTUOUS, HAD NO ANGULATION, AND HAD 20% STENOSIS. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THE DEVICE WAS INSERTED THROUGH A HEMOSTATIC VALVE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE BALLOON COVER, REMOVING THE STYLET, OR REMOVING 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 WITH A CONTRAST TO SALINE RATIO OF 50/50. THE DEVICE WAS INFLATED WITH AN UNKNOWN INDEFLATOR THAT HAS BEEN USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494613 ↗
• MalfunctionOct 4, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO 7MM2CM 80 WAS USED BUT IT RUPTURED AT FOUR ATMOSPHERES. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WILL NOT BE RETURNED DUE TO INFECTIOUS DISEASE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9158465 ↗
• MalfunctionJul 24, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO 7MM2CM 80 WAS INSERTED AND INFLATED, HOWEVER IT RUPTURED AT SIX ATMOSPHERES WITHIN ITS NOMINAL PRESSURE DURING ITS INITIAL INFLATION. THERE WERE NO REPORTED PATIENT INJURIES. RUPTURE WAS CONFIRMED BY CONTRAST MEDIA LEAKAGE. THE POWERFLEX PRO WAS REPLACED WITH ANOTHER HIGH PRESSURE BALLOON, THEN THE PROCEDURE WAS COMPLETED. THE LESION WAS THE COMMON ILIAC ARTERY AND IT WAS HEAVILY CALCIFIED. . ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824104 ↗