POWERFLEX 4401002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032060018), received between Dec 26, 2017 and Sep 4, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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.

• 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 10MM X 2CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER EXPLODED WHEN THE DOCTOR TRIED TO INFLATE IT AND ALL OF THE ¿FRONT PIECE¿ OF THE BALLOON CATHETER REMAINED INSIDE THE PATIENT. THEREFORE, THE DOCTOR WHO WAS OPERATING THE PATIENT ASKED FOR A SURGEON TO REMOVE THE PIECE THAT WAS STILL INSIDE THE PATIENT AND AFTER THE INTERVENTION, THE PATIENT WAS OKAY. THE PRODUCT WAS STORED AS PER LABELING. THE DEVICE WAS OPENED IN A STERILE FIELD. SURGICAL INTERVENTION WAS NOT NECESSARY TO REMOVE THE SEPARATED PIECE. THE EVENT CAUSED AN 120 MINUTE INCREASE IN DURATION OF THE PROCEDURE. THE EVENT DID NOT CAUSE HOSPITALIZATION OR PROLONGED HOSPITALIZATION. THE PROCEDURE WAS TO PREPARE FOR A TRANSCATHETER PULMONARY VALVE REPLACEMENT. THE LESION HAD MODERATE TO SEVERE CALCIFICATION, MODERATE TORTUOSITY, MILD ANGULATION OF ABOUT 20 DEGREE, ABOUT 60% STENOSIS, AND WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSERTED THROUGH A HEMOSTATIC VALVE. THE BALLOON WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494488 ↗
• MalfunctionJan 7, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 10MM 2CM 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER RUPTURED WITHIN ITS RATED BURST PRESSURE (RBP). THE TARGET LESION WAS THE AORTOILIAC ARTERY WITH SEVERE CALCIFICATION. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560738 ↗
• MalfunctionDec 26, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING PRE-DILATION OF THE LEFT COMMON ILIAC ARTERY, THE 10MM 2CM 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT AT TWELVE ATMOSPHERES (12 ATM) DURING ITS SECOND INFLATION. THE MAXIMUM INFLATION PRESSURE WAS AT 12 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. AN APPROACH WAS MADE (INITIALLY) FROM THE LEFT COMMON FEMORAL ARTERY AND THE BALLOON WAS INFLATED TO EIGHT ATMOSPHERES (8ATM) DURING ITS FIRST INFLATION. THE DEVICE WAS PREPPED AS PER INSTRUCTION FOR USE (IFU). THE LESION WAS SEVERELY CALCIFIED WITH LITTLE VESSEL TORTUOSITY. THERE WAS EIGHTY PERCENT STENOSIS NOTED. THE DEVICE WAS NOT USED FOR CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO KINK OR OTHER DAMAGED NOTED PRIOR TO INSERTION OF THE PRODUCT INTO THE PATIENT. THE SAME UNKNOWN INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE CATHETER WAS NOT ACUTELY BEND. THERE WAS LITTLE RESISTANCE FELT WHILE CROSSING THE LESION. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE PRODUCT WAS REMOVED INTACT AND IN ONE PIECE FROM THE PATIENT. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED DUE TO S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520926 ↗
• MalfunctionApr 22, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SMART CONTROL STENT (ILIAC 8X60) WOULD NOT CROSS THE LESION IN THE LEFT EXTERNAL ILIAC ARTERY. INITIALLY, AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY AND A SMART STENT (10/30) WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY. ADDITIONALLY, A POWERFLEX PRO BALLOON CATHETER (10MM2CM 80) WAS INSERTED FOR POST-DILATION, HOWEVER, THE DEVICE GOT CAUGHT ON THE EDGE OF THE STENT AND RUPTURED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS DUE TO INFECTIOUS DISEASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535820 ↗
• MalfunctionDec 26, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE POWER FLEX PRO WAS DELIVERED TO THE LESION AND INFLATED. HOWEVER IT RUPTURED AT SIX (6) ATMOSPHERE (ATM). IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED BUT THE WAS PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7146944 ↗