POWERFLEX 4400904SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032059937), received between Nov 7, 2016 and Feb 3, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A POWERFLEX PRO 9MM X 4CM 80 BALLOON CATHETER RUPTURED DUE TO SEVERE CALCIFICATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING AN UNKNOWN REPLACEMENT DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE DID MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND AT ANY POINT DURING THE PROCEDURE. THE DEVICE DID NOT KINK AT ANY TIME DURING THE PROCEDURE. THERE WERE NO ANOMALIES NOTED AFTER THE DEVICE WAS DELIVERED TO THE LESION. THE SAME UNKNOWN INDEFLATOR USED SUCCESSFULLY WITH OTHER UNKNOWN DEVICES. THERE WERE NO ANOMALIES NOTED WHILE INFLATING THE DEVICE WITH POSITIVE PRESSURE. A CONTRALATERAL APPROACH WAS NOT USED. THE LESION WAS AT THE ILIAC ARTERY. TARGET SITE VESSEL WAS SEVERELY TORTUOUS. ACCESS SITE WAS SEVERELY CALCIFIED WITH MODERATE TORTUOSITY. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WAS DISCARDED; THEREFORE, IT WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292609 ↗
• MalfunctionMay 12, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED WITH TWO POWERFLEX PRO BALLOON CATHETERS (6MM AND 7MM) AND WHEN A THIRD POWERFLEX PRO (9MM X 4CM X 80CM) WAS USED TO ADD MORE INFLATION, IT RUPTURED AT 10 ATMOSPHERIC PRESSURE (ATM). THEREFORE, THE PHYSICIAN SUSPENDED THE PRE DILATION AND A SMART STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS THE ILIAC ARTERY WHICH HAD CHRONIC TOTAL OCCLUSION (CTO) AND STENOSIS. THE LESION WAS SEVERELY CALCIFIED. THE VESSEL TORTUOSITY WAS MILD. THERE WAS 90% STENOSIS. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THE DEVICE WAS PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE CONTRAST TO SALINE RATIO WAS 1:1. A NON-CORDIS INFLATION DEVICE WAS USED. THE SAME INDEF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10047591 ↗
• MalfunctionApr 16, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 9MMX4CM POWERFLEX PRO WAS INSERTED FOR A POST DILATION AFTER AN UNKNOWN STENT WAS IMPLANTED, HOWEVER IT RUPTURED. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE ILIAC ARTERY. THE PHYSICIAN COMMENTED THIS ISSUE MIGHT HAVE OCCURRED AS IT HIT THE STENT EDGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8518237 ↗
• MalfunctionJan 18, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO PTA (9MM4CM 80) BALLOON CATHETER WAS INSERTED AS A POST DILATION AFTER A STENT WAS IMPLANTED. HOWEVER, THE POWERFLEX PRO BALLOON CATHETER RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THE LESION WAS THE ILIAC ARTERY. AS OF NOTE: ¿THE PHYSICIAN COMMENTED THAT THE ISSUE MIGHT HAVE OCCURRED DUE TO A HIT WITH THE EDGE OF THE STENT¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8260772 ↗
• MalfunctionAug 23, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE POWER FLEX PRO BALLOON CATHETER WAS DELIVERED AND INFLATE HOWEVER, IT RUPTURED AT 4 ATM. THEREFORE IT WAS REPLACED WITH A NEW POWER FLEX PRO BALLOON CATHETER, A SMART STENT WAS IMPLANTED IN THE TARGET LESION WITHOUT ANY ISSUE AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE COMMON ILIAC ARTERY. 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 6812988 ↗
• MalfunctionNov 7, 2016Burst Container or Vessel; Burst Container or Vessel

  DURING THE USE OF A POWERFLEX PRO (9MM4CM 80) IT WAS REPORTED THAT THE BALLOON CATHETER WAS DELIVERED TO THE LESION AND INFLATED. HOWEVER IT RUPTURED AT 10 ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION. THEREFORE IT WAS REMOVED INTACT FROM THE PATIENT AND A NEW OF THE SAME-SIZE BALLOON CATHETER WAS USED. THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. 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. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THIS WAS A TRANS-JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) CASE FOR PORTAL HYPERTENSION. THE TARGET LESION WAS THE UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6084627 ↗