POWERFLEX 4400604XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032059524), received between Jun 5, 2017 and May 8, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM 4CM POWERFLEX PRO WAS USED. HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER (NON-CORDIS) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A PTA CASE. THE LESION WAS THE COMMON FEMORAL ARTERY. AN .035 NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270889 ↗
• MalfunctionMar 13, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MM X 4CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED FOR POST DILATION IN A PTA CASE BUT RUPTURED BEFORE THE PRESSURE REACHED ITS NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED BY REPLACING THE COMPLAINT DEVICE WITH ANOTHER UNKNOWN DEVICE AND POST DILATION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS REPORTED TO BE THE COMMON ILIAC ARTERY. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16533620 ↗
• MalfunctionJun 24, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 4CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING ITS NOMINAL PRESSURE DURING PRE-DILATION OF THE ILIAC ARTERY. AS A RESULT, THE 6MM X 4CM 135CM POWERFLEX PRO PTA BALLOON CATHETER WAS REPLACED BY A NON-CORDIS BALLOON CATHETER OF THE SAME SIZE. THIS WAS FOLLOWED BY THE IMPLANTATION OF A S.M.A.R.T. SELF-EXPANDING STENT (SES). AFTER STENT IMPLANTATION, AN 8MM X 4CM 135CM POWERFLEX PRO PTA BALLOON CATHETER WAS TO BE USED FOR POST-DILATION WHEN THE BALLOON RUPTURED BEFORE REACHING ITS NOMINAL PRESSURE. THE 8MM X 4CM 135CM PTA BALLOON CATHETER WAS REPLACED BY A SECOND NON-CORDIS BALLOON CATHETER WHICH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. AN APPROACH WAS MADE FROM THE LEFT UPPER EXTREMITY FOR THIS PROCEDURE. BOTH OF THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800091 ↗
• MalfunctionMay 18, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THE 6MM X4CM X 135CM POWERFLEX PRO PTA BALLOON CATHETER (BC) WAS INFLATED WITH NORMAL AIR PRESSURE, BUT THE BALLOON BURST AND COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841809 ↗
• MalfunctionApr 28, 2021Deflation Problem; Deflation Problem

  AS REPORTED, THE 6MM X 4CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE COMPLETELY DEFLATED DURING THE DEFLATING PROCESS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED IN THE CATH LAB, IN NORMAL CONDITION AT ROOM TEMPERATURE. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS PER USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WERE NO ANOMALIES NOTED WHILE PULLING NEGATIVE PRESSURE. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO UNUSUAL FORCE USED DURING THE PROCEDURE. THERE WAS NO LEAKAGE NOTED FROM THE BALLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737133 ↗
• MalfunctionJul 22, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 6MM X 4CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 5 ATMOSPHERES (ATM). THEREFORE, THE DEVICE WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A PTA CASE. THE LESION WAS AT THE RIGHT SUBCLAVIAN ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308721 ↗
• MalfunctionJan 9, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MMX4CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) BURST IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND COULD NOT BE OPERATED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571983 ↗
• MalfunctionJun 5, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT FIVE (5) POWERFLEX PRO BALLOON CATHETER (BC) BURST AT TEN TO TWELVE ATMOSPHERE (10-12 ATM) DURING THE INTERVENTION IN THE SAME PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICE WAS PREP NORMALLY. THERE WERE NO DIFFICULTY INFLATING THE BALLOONS DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, 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 PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. CONTRAST MEDIA USED WAS SOLUTRAST 350. THE CONTRAST TO SALINE RATIO WAS CM+NACL. THE TYPE AND BRAND OF INFLATION DEVICE USED WAS ARCROYAL WHICH WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, GUIDE CATHETER, AND THROUGH THE VESSEL. THERE WERE NO DIFFICULTY CROSSING THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6610691 ↗