POWERFLEX 4157040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20705032001837), received between Jun 26, 2019 and Mar 7, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K032737); they may or may not involve this specific model.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AS 20 ATMOSPHERES (ATM). THE BALLOON WAS REMOVED FULL INTACT AND A NEW 7MM X 4CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN ARTERIAL ANASTOMOSIS STENOSIS WHICH WAS NOT CALCIFIED OR TORTUOUS AND HAD A STENOSIS PERCENTAGE GREATER THAN 80%. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS 50 SALINE/50 CONTRAST. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547915 ↗
• MalfunctionDec 9, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE POWERFLEX EXTREME 7X4 BALLOON WOULD NOT INFLATE TO NOMINAL AND CONTRAST LEAKAGE WAS NOTICED IN THE VESSEL FROM THE BALLOON. THE LEAK WAS NOTICED WHILE GIVING POSITIVE PRESSURE. THE LEAK WAS NOTICED AT 1ATM. THE DEVICE WAS REMOVED INTACT AND DISCARDED. AN ADDITIONAL/SECOND POWERFLEX EXTREME DEVICE OF SAME SIZE WAS OPENED AND USED; HOWEVER, THE NEW DEVICE ALSO HAD CONTRAST LEAKAGE. THAT DEVICE WAS REMOVED INTACT AND DISCARDED. THE CASE WAS COMPLETED WITH AN ADDITIONAL POWERFLEX EXTREME BALLOON. THE DEVICES WERE OPENED AND PREPPED IN A STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOTED TO HAVE MAINTAINED NEGATIVE PRESSURE. THE DEVICES TRACKED OVER THE UNKNOWN WIRE TO THE DESIRED LESION. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVERS, STYLETS, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES PRIOR TO INSERTING THE DEVICES INTO THE PATIENT. THE DEVICES WERE NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOONS THROUGH THE ROTATING HEMOSTATIC VALVE, OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15952110 ↗
• MalfunctionDec 9, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE POWERFLEX EXTREME 7X4 BALLOON WOULD NOT INFLATE TO NOMINAL AND CONTRAST LEAKAGE WAS NOTICED IN THE VESSEL FROM THE BALLOON. THE LEAK WAS NOTICED WHILE GIVING POSITIVE PRESSURE. THE LEAK WAS NOTICED AT 1ATM. THE DEVICE WAS REMOVED INTACT AND DISCARDED. AN ADDITIONAL/SECOND POWERFLEX EXTREME DEVICE OF SAME SIZE WAS OPENED AND USED; HOWEVER, THE NEW DEVICE ALSO HAD CONTRAST LEAKAGE. THAT DEVICE WAS REMOVED INTACT AND DISCARDED. THE CASE WAS COMPLETED WITH AN ADDITIONAL POWERFLEX EXTREME BALLOON. THE DEVICES WERE OPENED AND PREPPED IN A STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOTED TO HAVE MAINTAINED NEGATIVE PRESSURE. THE DEVICES TRACKED OVER THE UNKNOWN WIRE TO THE DESIRED LESION. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVERS, STYLETS, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES PRIOR TO INSERTING THE DEVICES INTO THE PATIENT. THE DEVICES WERE NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOONS THROUGH THE ROTATING HEMOSTATIC VALVE, OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15952100 ↗
• MalfunctionOct 26, 2020Leak/Splash; Leak/Splash

  DURING USE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON OF 7X4 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER USING A SYRINGE; HOWEVER, THE BALLOON INFLATED MINIMALLY AND NOTED TO HAVE LEAKED CONTRAST. THE DEVICE WAS REMOVED FROM THE PATIENT¿S BODY. THEREFORE, ANOTHER UNKNOWN BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON WAS PREPPED IN A STERILE FIELD AS PER INSTRUCTION FOR USE (IFU) WITH 50/50 SALINE/CONTRAST RATIO. THE INTENDED VESSEL WAS A DIALYSIS FISTULA WITH NO CALCIFICATIONS, TORTUOSITY, OR CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, 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. THE BALLOON WAS ADVANCED OVER THE WIRE IN PATIENT VESSEL. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734602 ↗
• MalfunctionOct 2, 2020Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  DURING DILATATION OF VENOUS STENOSIS, THE BALLOON OF A 7MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT FIVE (5) ATMOSPHERES (ATM). THEREFORE, THE BALLOON WAS CHANGED. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS TRAINED TO THE POWERFLEX EXTREME DEVICE. THE DEVICE WAS OPENED IN STERILE FILED. THE VESSEL LEVEL OF ANGULATION IS NONE. THE VESSEL LEVEL OF CALCIFICATION AND TORTUOSITY IS MILD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THE DEVICE WAS PREP NORMALLY. THE CONTRAST TO SALINE RATIO IS 60% SALINE WATER + 40% CONTRAST. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES AND IT WAS THE FIRST USE OF INDEFLATOR DURING THE PROCEDURE. THE BALLOON INFLATED NORMALLY. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE BUT THE TERUMO .035 GUIDEWIRE RUBS INSIDE THE BALLOON. 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 EVALUATION BECAUSE IT WAS CONTAMINATED AND NOT KEPT BY THE ESTABLISHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621029 ↗
• MalfunctionSep 24, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF 7MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS MINIMALLY INFLATED AND LEAKED UNKNOWN CONTRAST. THEREFORE, THE BALLOON WAS REMOVED, AND ANOTHER UNKNOWN BALLOON WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON ADVANCED OVER THE UNKNOWN WIRE IN PATIENT¿S VESSEL. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOONS USING A SYRINGE WITH 50/50 SALINE AND CONTRAST RATIO. THE OPERATOR WAS TRAINED TO THE POWERFLEX EXTREME DEVICE. THE DEVICE WAS STORED AS PER LABELING AND PREPPED IN STERILE FILED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). GE OMNIPAQUE CONTRAST MEDIA WAS USED. THE CONTRAST TO SALINE RATIO WAS 50/50. A SYRINGE INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10579603 ↗
• MalfunctionAug 5, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE PHYSICIAN ATTEMPTED HAND INFLATION WITH 10CC SYRINGE, USING 50/50 CONTRAST/SALINE RATIO, HOWEVER, THE BALLOON OF 7 X 4 X 80 POWERFLEX EXTREME BEGAN TO LEAK CONTRAST AND WOULD NOT INFLATE TO NOMINAL. THEREFORE, THE DEVICE WAS REMOVED, AND ANOTHER BALLOON CATHETER (UNKNOWN) WAS OPENED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PLACED OVER AN UNKNOWN WIRE INTO THE PATIENT. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. THE BALLOON WAS PREPPED AS PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, 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 DEVICE WAS PLACED OVER AN UNKNOWN WIRE INTO THE PATIENT. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE CATHETER EVER HAS NEVER BEEN IN AN ACUTE BEND. THERE WERE DAMAGES NOTED TO THE BALLOON AFTER IT WAS REMOVED FROM THE PATIENT. IT WAS NOTED THAT THE ACCOUNT HAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370068 ↗
• MalfunctionJul 17, 2020Leak/Splash; Leak/Splash

  AS REPORTED, WHEN THE BALLOON OF A 7MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INTRODUCED IN THE PATIENT, UNKNOWN CONTRAST LEAKED, AND IT WAS VISUALIZED UNDER FLUORO. THEREFORE, THE BALLOON WAS REMOVED, AND ANOTHER UNKNOWN BALLOON WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED, HANDLED PER THE INSTRUCTION FOR USE (IFU), AND OPENED IN STERILE FIELD. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. 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 WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE BALLOON CATHETER WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THERE WAS NO DIFFICULTY TRACKING THE CATHETER THROUGH THE VESSEL OR LESION. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290351 ↗
• MalfunctionJul 13, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 7X4 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS RUPTURED DURING ITS FIRST INFLATION AT 20 ATMOSPHERES (ATM) INTRA STENT (VENOUS GRAFT ANASTOMOSIS). THE PROCEDURE WAS COMPLETED USING A NON CORDIS PTA BALLOON CATHETER. THE BALLOON WAS REMOVED INTACT AND THERE WAS NO HARM WAS CAUSED TO THE PATIENT. THE INTENDED PROCEDURE WAS FOR A LEFT HEMODIALYSIS FISTULA VENOUS GRAFT. THERE WAS NO CALCIFICATION. THERE WAS MILD VESSEL TORTUOSITY. THE VENOUS GRAFT HAD 75% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). 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 PREPPED NORMALLY WITH 50/50 CONTRAST TO SALINE RATIO USING A NON CORDIS INFLATION DEVICE. THE USER WAS ABLE TO DEPRESS THE PLUNGER INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE AND THE PLUNGER DID DEPRESS INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THERE WAS NO RESISTANCE/FRICTION W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10265647 ↗
• MalfunctionJun 29, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 7MM X 4CM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT INFLATE TO NOMINAL PRESSURE AND A LEAK WAS NOTICED UPON INFLATION. THEREFORE, ANOTHER UNKNOWN BALLOON WAS USED TO FINISH THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE VESSEL LEVEL OF CALCIFICATION AND TORTUOSITY IS NONE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. INITIALLY, THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTION FOR USE. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. 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 WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE DEVICE WAS OPENED IN A STERILE FIELD AND PREPPED AS NORMAL USING A 50/50 CONTRAST SALINE RATIO. THE DEVICE WAS INSERTED INTO THE PATIENT. THE BALLOON CATHETER WAS NOT KINKE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10206535 ↗
• MalfunctionJun 25, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF 7X4 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) HAS LEAKAGE AND WOULD NOT INFLATE UPON INITIAL USE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS USED IN THE PATIENT. THE INTENDED PROCEDURE WAS A/V FISTULOGRAM WITH INTERVENTION. THE LESION WAS NOT CALCIFIED. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR THERE 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 WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THE CONTRAST MEDIA USED WAS GE OMNIPAQUE 300 WITH A 50:50 CONTRAST SALINE RATIO. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE PLUNGER DEPRESSED INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10195538 ↗
• MalfunctionJun 23, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 7MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT INFLATE UPON INITIAL USE (BALLOON LEAKED). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FILED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183980 ↗
• MalfunctionApr 21, 2020Leak/Splash; Leak/Splash

  AS REPORTED, A 7MM X 40MM 80CM POWER FLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT INFLATE UPON INITIAL USE AND WOULD LEAK FROM THE TIP. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN PRODUCT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER OR 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 (I.E. MAINTAIN NEGATIVE PRESSURE). A NON-CORDIS CONTRAST MEDIA WAS USED WITH A 50:50 SALINE RATIO. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE INTENDED PROCEDURE OR TARGET LESION WAS FISTULA. 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 USER WAS ABLE TO DEPRESS THE PLUNGER INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THE DEVICE WILL NOT BE R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9981569 ↗
• MalfunctionJun 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 7 X 40 MM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER RUPTURED AT 8 ATMOSPHERE (ATM). THE BALLOON WAS DELIVERED WITHOUT INCIDENT AND REMOVED UPON RUPTURE WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS INSPECTED OUTSIDE THE PATIENT AND CONFIRMED TO BE PUNCTURED. IT WAS USED INTENDING TO DILATE A LESION IN THE CEPHALIC VEIN. THE LESION WAS NOT CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 80 %. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREP NORMALLY. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. 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 BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE CONTRAST TO SALINE RATIO WAS 50%. THE SAME INDEFLATOR WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736471 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032737. One submission often covers many models, so check the product and lot details in each record.

• Z-1477-2020 · Jan 8, 2020 · Terminated
  Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S