POWERFLEX 4401204SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032060179), received between Jul 31, 2018 and Aug 22, 2022 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 12MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED HORIZONTALLY DURING AN INFLATION TO TREAT A LEFT BRACHIAL CEPHALIC VEIN (BCV) OCCLUSION. THE BALLOON HAD BURST DURING AN INFLATION TO 8 ATMOSPHERES (ATM), AND THE RUPTURE CAUSED PART OF THE BALLOON TO DETACH FROM THE POWERFLEX PRO BALLOON CATHETER. AS A RESULT, THE 12MM X 4CM POWERFLEX PRO BALLOON CATHETER AND AN UNKNOWN CATHETER SHEATH INTRODUCER (CSI) WERE REMOVED FROM THE PATIENT OVER A STORQ GUIDEWIRE THAT WAS BEING USED FOR THE PROCEDURE. AFTER REMOVAL OF THE BALLOON AND UNKNOWN CSI, A NECK INCISION WAS MADE AT THE SKIN LEVEL OF THE ACCESS SITE AND THE SEPARATED PORTION OF THE BALLOON WAS REMOVED WITH A PAIR OF SURGICAL FORCEPS. PRIOR TO THE BALLOON RUPTURE, THE LESION WAS PRE-DILATED WITH A 3MM .018 SABER PTA BALLOON CATHETER. THIS WAS FOLLOWED BY FURTHER PRE-DILATION WITH A 6MM POWERFLEX PRO PTA BALLOON CATHETER, AND THEN A 10MM POWERFLEX PRO PTA BALLOON CATHETER. THE 12MM X 4CM 80CM POWERFLEX PRO WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264920 ↗
• InjuryOct 11, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 12MM X 4CM 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WHEN TAKEN ABOVE THE RATED BURST PRESSURE WHICH CAUSED THE TIP TO BREAK OFF FROM THE CATHETER WITH HALF OF THE BALLOON ON IT. THE PORTION THAT BROKE OFF WAS SNARED OUT OF THE PATIENT. THE BALLOON CATHETER WAS TAKEN ABOVE THE RATED BURST PRESSURE ON THE INSTRUCTIONS FOR USE BECAUSE THERE WAS A VERY TIGHT LESION IN SUBCLAVIAN VEIN PER THE PHYSICIAN. THE MAXIMUM INFLATION PRESSURES THE BALLOON WAS TAKEN TO WHERE IT CAUSED THE DEVICE TO BURST WAS 12-14 ATM AS PER THE TECH. NO INJURY WAS CAUSED TO THE PATIENT. THE INTENDED PROCEDURE/TARGET LESION WAS THE SUBCLAVIAN VEIN. VESSEL / LESION CHARACTERISTICS: THE LESION HAD SEVERE CALCIFICATION. THE PERCENTAGE OF STENOSIS WAS 95%.THE VESSEL TORTUOSITY AND VESSEL ANGULATION WERE UNKNOWN. IT IS UNKNOWN IF THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THE DEVICE WAS USED IN THE PATIENT . THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605311 ↗
• MalfunctionJul 6, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 12MM X 4CM X 80CM POWER FLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED, IT WAS DELIVERED TO THE LESION AND INFLATED DURING ITS INITIAL INFLATION. 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 CONTRAST TO SALINE RATIO WAS 1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON INFLATED NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS 6-ATMOSPHERES PRESSURE (ATM). THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINK/BENT NOTED AFTER THE 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 AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10234355 ↗
• MalfunctionMay 4, 2020Burst Container or Vessel; Burst Container or Vessel

  THE 12MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 4 ATMOSPHERES (ATM) DURING USE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS SINCE IT WAS DISCARDED DUE TO INFECTIOUS DISEASES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022445 ↗
• MalfunctionOct 31, 2019Material Rupture; Material Rupture

  AS REPORTED, THE 12MM X 4CM 80CM POWERFLEX PRO BALLOON CATHETER (BC) RUPTURED. AN UNKNOWN GUIDEWIRE WAS USED TO CROSSED THE LESION. THE BALLOON RUPTURED AT THREE ATMOSPHERES (3 ATM). THE LESION WAS THE AORTA PART. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9262707 ↗
• MalfunctionOct 17, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING A STENT GRAFT PROCEDURE IN AN ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) CASE, A POWERFLEX PRO BALLOON CATHETER RUPTURE WAS USED FOR POST DILATION AT THE ILIAC ARTERY; HOWEVER IT RUPTURED AT EIGHT ATMOSPHERE (8 ATM) DURING ITS SECOND INFLATION. THERE WAS NO PATIENT INFORMATION. THE POWERFLEX WAS REPLACED WITH A SAME SIZE COMPETITOR'S BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE TARGET LESION IS THE IN-STENT ILIAC ARTERY WITH MODERATE TORTUOSITY AND NO CALCIFICATION. THERE WERE NO DIFFICULTY NOTED IN THE BALLOON 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. A COMPETITOR'S INFLATION DEVICE WAS USED. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WAS DISCARDED IN THE HOSPITAL. NO OTHER INFORMATION WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202500 ↗
• MalfunctionJul 31, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE POWER FLEX PRO RUPTURED AT SIX ATMOSPHERE (6 ATM) WHICH WAS WITHIN ITS RATED BALLOON PRESSURE. THERE WAS NO PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY WITH CALCIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7735032 ↗