POWERFLEX 4400622XRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032059647), received between Nov 15, 2019 and Jul 7, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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.

• MalfunctionJul 7, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO 6MM 22CM BALLOON WAS RUPTURED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14948363 ↗
• MalfunctionSep 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN INTERVENTIONAL PROCEDURE, A TECH WENT TO TAKE A 6MM22CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON OUT OF STERILE SLEEVE TO USE BUT THERE WAS DIFFICULTY REMOVING THE BALLOON. AND IT RIPPED OFF OF THE SHAFT. ANOTHER POWERFLEX WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A PERIPHERAL INTERVENTION. THERE WAS NO DAMAGE TO THE PACKAGING OF THE PRODUCT. IT WAS STORED ON THE SHELF OUTSIDE OF PROCEDURE ROOM. THERE WAS NO DAMAGE NOTED TO THE DEVICE PRIOR TO ATTEMPTING TO REMOVE IT. THE TECH GRASPED THE HUB TO GENTLY TAKE THE CATHETER OUT. THERE WAS NO EXCESSIVE FORCE USED. PATIENT DETAILS WERE REQUESTED BUT WERE NOT AVAILABLE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12515538 ↗
• MalfunctionAug 16, 2021Difficult to Remove; Difficult to Remove

  DURING FEMORAL ANGIOPLASTY, IT WAS NOT POSSIBLE TO NAVIGATE WITH THE 6MM X 22CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC). THERE WAS DIFFICULTY ACCESSING THE LESION WITH AN AQUATRACK GUIDEWIRE. THE DOCTOR ASSESSED THAT IT COULD BE THE SUPPORT FOR THE GUIDE WIRE, MADE THE CHANGE, BUT THE DIFFICULTY OF NAVIGATING WITH THE BALLOON PERSISTED. THE BALLOON CATHETER WAS NOT REMOVED EASILY. TO CONTINUE THE PROCEDURE, IT WAS NECESSARY TO REPLACE THE BALLOON CATHETER WITH ANOTHER POWERFLEX PRO. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS A TRAINED POWERFLEX PRO USER. THE INTENDED PROCEDURE WAS AN ARTERY UNBLOCKING. THE TARGET SITE WAS THE FEMORAL ARTERY. THE ACCESS SITE WAS THE RIGHT FEMORAL. A CONTRALATERAL APPROACH WAS NOT USED. THE LESION WAS MODERATELY CALCIFIED. THERE WAS LITTLE VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12323461 ↗
• MalfunctionFeb 17, 2021Partial Blockage

  AS REPORTED, A 6MM X 22CM X 135CM POWER FLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER FAILED TO ADVANCE OVER A .035¿ NON-CORDIS HYDROPHILIC WIRE. UPON WETTING THE WIRE WITH A WET 4 X 4, ATTEMPTS TO ADVANCE THE POWER FLEX PRO PTA BALLOON OVER THE WIRE WERE MET WITH SIGNIFICANT RESISTANCE TO THE POINT THE PHYSICIAN GAVE UP. IT WAS NOTED THAT IT WAS POSSIBLE THE DIFFICULTY WAS CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL, BUT THE USER WAS UNABLE TO TELL. THE PHYSICIAN USED A NON-CORDIS DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTION FOR USE (IFU). THE INTENDED PROCEDURE WAS A PTA OF SFA FOLLOWING ATHERECTOMY. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. A CONTRALATERAL APPROACH WAS USED. THE DEVICE DID NOT KINK NOR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK NOR BEND AT ANY TIME. THE PRODUCT, NOR ANY OF THE OTHER DEVICES USED WITH IT, HAD NOT BEEN RESTERILIZED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338208 ↗
• MalfunctionJan 2, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 6MM 22CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER RUPTURED WHILE BEING INFLATED ON THE SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PROPERLY PREPPED ACCORDING THE IFU MAINTAINING NEGATIVE PRESSURE. THE DEVICE WAS PROPERLY STORED AND HANDLED ACCORDING TO THE IFU. THE LESION WAS SEVERELY CALCIFIED, WITH MODERATE VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. 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. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE CONTRAST TO SALINE RATIO WAS FIFTY-FIFTY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. 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. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE MAXIMUM INFLATION PRESSURE WAS 13-14 ATMOSPHERES (ATM). TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538515 ↗
• MalfunctionNov 19, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 22CM 135 POWERFLEX PRO RUPTURED AND FAILED TO DEFLATE PROPERLY INSIDE OF A PATIENT AFTER INITIAL INFLATION TO 6 ATMOSPHERES (ATM). THERE WAS NO REPORTED INJURY. PRIOR TO USE, THE DEVICE WAS STORED IN THE CATH LAB INSIDE A CART AND WAS STORED FOR LESS THAN 3 MONTHS. THE DEVICE WAS STORED, HANDLED AND PREPPED AS PER INSTRUCTIONS FOR USE (IFU). IT WAS PREPPED NORMALLY AND USED NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY NOTED WHEN REMOVING THE STYLET OR ANY COMPONENTS OF THE STERILE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY WHEN REMOVING THE BALLOON COVER. THE PRODUCT WAS INSPECTED PRIOR TO USE AND IT APPEARED TO BE NORMAL. THERE WERE NO KINKS OR DAMAGES PRIOR TO INSERTION TO THE PATIENT. THERE WAS NO RESISTANCE OR FRICTION FELT WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THROUGH THE GUIDE CATHETER. NO UNUSUAL FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. THERE WAS LEAKAGE NOTICED FROM THE BALLOON DURING THE PROCEDURE AND AFTER IT WAS REMOVED. THERE WAS NO TORTUOSITY ON THE VESSEL NOTED. THE DEVICE WAS USED FOR CHRONIC TOTAL OCCLUSION (CTO) AFTER THE ATHERECTOMY WAS DON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9343960 ↗
• MalfunctionNov 15, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM X 22CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS RUPTURED AROUND 7 ATMOSPHERES (ATM) AND FAILED TO FULLY INFLATE INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328840 ↗