POWERFLEX 4400802SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20705032059777), received between Nov 22, 2016 and Jun 24, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MM X 2CM X 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED BUT IT RUPTURED AT 2 ATMOSPHERES (ATM). THEREFORE, IT WAS REPLACED ANOTHER UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12056729 ↗
• MalfunctionMar 15, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MM X 2CM X 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR POST-DILATION. HOWEVER, IT RUPTURED APPROXIMATELY 12 ATMOSPHERES (ATM) 10-SECONDS INFLATION. THEREFORE, IT WAS REPLACED WITH A NEW 8-2 NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT COMMON ILIAC ARTERY. AN APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY. A 10-4 NON-CORDIS STENT WAS IMPLANTED. THE DEVICE WAS NOT OPENED IN STERILE FIELD. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS DISCARDED DUE TO SUSPICIOUS INFECTIOUS DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483648 ↗
• MalfunctionSep 16, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MM X 2CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED, HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. THE VESSEL LEVEL OF ANGULATION AND TORTUOSITY IS MILD. THE VESSEL LEVEL OF CALCIFICATION IS SEVERE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON DID NOT INFLATE AS IT RUPTURED. THERE WAS NO LEAKAGE NOTED FROM THE BALLOON, SHAFT, HUB, OR UNKNOWN SEGMENT. THE CATHETER WAS TORQUED AGAINST RESISTANCE. THERE WERE NO KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10542099 ↗
• MalfunctionMar 5, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8MMX2CM POWERFLEX PRO 80 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ATTEMPTED TO BE USED POST DILATION FOR AN ILIAC ARTERY LESION, HOWEVER, BALLOON RUPTURED WITHIN ITS NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NON CORDIS BALLOON CATHETER. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO VISIBLE DAMAGE TO PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY 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 INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. AN UNKNOWN INDEFLATOR WAS USED SUCCESSFULLY WITH THE OTHER DEVICES. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PLUNGER DID DEPRESS INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE AND THE BALLOON DID INFLATE NORMALLY. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THE DEVICE WILL NOT BE RETURN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9792349 ↗
• MalfunctionJul 11, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8MMX2CM POWERFLEX PRO PERCUTANEOUS CORONARY ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS INFLATED AS A PRE-DILATION, HOWEVER IT RUPTURED WITHIN ITS NOMINAL PRESSURE. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE ILIAC ARTERY. THE DEVICE WAS INSPECTED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND IT PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE BC WAS REMOVED EASILY AND INTACT (IN ONE PIECE) FROM THE PATIENT. THE POWERFLEX PRO WAS REPLACED WITH A NEW UNKNOWN DEVICE AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8782153 ↗
• MalfunctionApr 1, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWER FLEX PRO WAS USED FOR A POST DILATION AFTER A STENT WAS IMPLANTED, HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. IT WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS CONTINUED. THE LESION WAS THE ILIAC ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470983 ↗
• MalfunctionSep 6, 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 FIVE (5) TO SIX (6) ATMOSPHERE (ATM) DURING ITS INITIAL INFLATION. THEREFORE THE POWER FLEX PRO WAS REPLACED WITH AN UNKNOWN 8 MM*4 CM BALLOON CATHETER WHICH WAS INFLATED AT TEN (10) ATM AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. AN UNKNOWN 6F SHEATH INTRODUCER WAS INSERTED INTO THE VEIN OF THE LEFT FOREARM AND A NON CORDIS GUIDEWIRE (035*150) CROSSED THE LESION. THE TARGET LESION WAS THE LEFT BRACHIAL VEIN. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY WAS UNKNOWN. THE LESION WAS HEAVILY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE PREP NORMALLY. 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. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846485 ↗
• MalfunctionMar 27, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A POWERFLEX PRO BALLOON CATHETER RUPTURED AT 6 ATMOSPHERE (ATM). IT WAS UNKNOWN HOW THE PROCEDURE COMPLETED BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6437274 ↗
• MalfunctionNov 22, 2016Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A POWER FLEX PRO BALLOON RUPTURE AT ITS NORMAL PRESSURE. IT WAS UNKNOWN HOW THE PROCEDURE COMPLETED HOWEVER THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS 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 6123438 ↗
• MalfunctionNov 22, 2016Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A POWERFLEX PRO BALLOON WAS INFLATED IN THE LESION BUT IT RUPTURED AT ITS NOMINAL PRESSURE. IT WAS UNKNOWN HOW THE PROCEDURE COMPLETED BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS UNKNOWN. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS 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 6123437 ↗