POWERFLEX 4156040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 20705032001752), received between Nov 4, 2016 and Jun 27, 2025 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (24 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Leak/Splash; Leak/Splash

  AS REPORTED, CONTRAST APPEARED TO LEAK OUT THE BACK OF A 6MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, ON THE SIDE OF AN UNKNOWN SHEATH. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345627 ↗
• MalfunctionMar 8, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 20 ATMOSPHERES (ATM). A SECOND 6MM X 40MM POWERFLEX EXTREME PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865062 ↗
• MalfunctionDec 9, 2022Leak/Splash; Leak/Splash

  AS REPORTED, AFTER THE POWERFLEX EXTREME 6X4 80CM TRACKED OVER UNKNOWN WIRE TO THE DESIRED LESION, THE BALLOON COULD NOT INFLATE TO NOMINAL AS CONTRAST WAS NOTICED IN THE VESSEL FROM THE BALLOON. THE LEAK WAS NOTICED AT 1 ATM. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT AND DISCARDED. AN ADDITIONAL POWERFLEX PRO BALLOON WAS OPENED AND USED TO COMPLETE CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS OPENED AND PREPPED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). THE BALLOON WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE LESION WAS NO CALCIFIED. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY NOTED WHILE ADVANCING THE DEVICE THROUGH THE VESSEL. THERE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15953583 ↗
• MalfunctionJul 26, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX EXTREME 6X4 RUPTURED WHILE THE PRESSURE WAS RAISED DURING INFLATION OF THE BALLOON. THEREFORE, THE BALLOON COULD NOT BE USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PROCEDURE BEING PERFORMED WAS AN ARTERIOVENOUS FISTULAGRAM (AVF) WITH PTA. THE DEVICE WILL BE RETUNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15109152 ↗
• MalfunctionDec 22, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6X4 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER RUPTURED UPON INITIAL INFLATION AT 6 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6X4 80CM POWERFLEX EXTREME PTA CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND DELIVERED TO THE TARGET LESION IN THE CEPHALIC VEIN WITHOUT ISSUE. THE TARGET LESION HAD 80% FOCAL STENOSIS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS PREVIOUSLY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060350 ↗
• MalfunctionNov 8, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MM X 40MM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATM WHEN TREATING A 60% FOCAL STENOSIS IN THE VICINITY OF AN ARTERIAL ANASTAMOSIS. THEREFORE, ANOTHER POWERFLEX EXTREME PTA WITH THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTION FOR USE (IFU) AND DELIVERED TO THE TARGET LESION WITHOUT AN ISSUE. THE TARGET VESSEL WAS NOT CALCIFIED AND HAD MILD TORTUOSITY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR 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. A 50/50 CONTRAST TO SALINE RATIO WAS USED. A NON CORDIS INFLATION DEVICE WAS USED AND IT WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PLUNGER DEPRESSED INTO THE SYRINGE/INDEFLATOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771203 ↗
• MalfunctionOct 11, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING AN INTERVENTIONAL PROCEDURE, A 6X4 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AS IT WAS STARTING TO INFLATE AT 4ATM. THERE WAS NO REPORTED PATIENT INJURY AND THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606001 ↗
• MalfunctionOct 11, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING AN INTERVENTIONAL PROCEDURE, A 6X4 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AS IT WAS STARTING TO INFLATE AT 4ATM. THERE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT BALLOON. THERE WAS NO REPORTED PATIENT INJURY AND THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE LESION WAS FLISTULA. THERE WAS NO CALCIFICATION AND NO VESSEL TORTUOSITY. A FISTULAGRAM PROCEDURE WAS BEING PERFORMED. THE ACCESS SITE WAS THE LEFT ARM. 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. THE CONTRAST MEDIA RATIO OF CONTRAST TO SALINE RATIO WAS 30/70. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON CATHETER DID NOT KINK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605862 ↗
• MalfunctionJul 13, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MM X 4MM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED UPON INITIAL INFLATION. UPON INFLATION TO 3 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THERE WAS NO CALCIFICATION OR STENT PRESENT. THE LESION WAS A 90% FOCAL STENOSIS OF THE JUXTAPOSE ANASTOMOSIS OF AN END-STAGE RENAL PATIENT. THERE WERE NO DIFFICULTIES NOTED DURING PREP. A HALF SALINE/HALF CONTRAST RATIO WAS USED. A NON CORDIS INFLATION DEVICE WAS USED AND IT WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE NOR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE TARGET VESSEL HAD 90% STENOSIS, NO CALCIFICATION, AND NO TORTUOSITY. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12161992 ↗
• MalfunctionMar 25, 2021Leak/Splash; Leak/Splash

  WHEN PERFORMING THE SHUNT PROCEDURE, THE BALLOON OF 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED, BUT THE BALLOON WAS BLOWN EVEN THOUGH THE RATED BURST PRESSURE (RBP) WAS NOT RAISED. AS THE BALLOON CONTRACTS IN THE STATE, THE PHENOMENON OF FALLING OUT CONTINUOUSLY OCCURRED, SO A REQUEST FROM THE HOSPITAL TO RECOVER THE ENTIRE AMOUNT OCCURRED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS BECAUSE THE NURSE ACCIDENTALLY DISCARDED IT AND DID NOT HAVE IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567258 ↗
• MalfunctionJan 7, 2021Leak/Splash; Leak/Splash

  A PINHOLE WAS NOTED ON THE BALLOON OF 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC). THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A NON-CORDIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PINHOLE OBSERVED WAS ALWAYS AT THE DISTAL END OF THE BALLOON. IT WAS MENTIONED THAT THIS WAS THE 7TH BALLOON OF THE SAME LOT TO HAVE A PINHOLE. ADDITIONAL INFORMATION WAS OBTAINED FROM A REQUESTED ANALYSIS OF THE STERILE DEVICES THAT WERE RETURNED AND IT WAS OBSERVED THAT ANOTHER POWERFLEX BALLOON HAD LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11131993 ↗
• MalfunctionDec 10, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED WHILE ATTEMPTING TO TREAT A STENOSED CEPHALIC VEIN. THE BALLOON WAS DELIVERED WITHOUT COMPLICATION AND REMOVED WITHOUT INCIDENT (INTACT). THERE WAS NO HARM CAUSED TO THE PATIENT. THE DEVICE WAS STORED IN THE CATH LAB HANGING FROM A MOUNTED RACK IN A CABINET IN A TEMPERATURE-CONTROLLED ROOM, FOR LESS THAN SIX MONTHS. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE CONTRAST MEDIA USED WAS GE OMNIPAQUE AND THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE TARGET LESION WAS THE FOCAL STENOSIS IN THE CEPHALIC VEIN. THE LESION WAS NOT CALCIFIED AND THERE WAS LITTLE VESSEL TORTUOSITY. THERE WAS EI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983557 ↗
• MalfunctionNov 21, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6 X 4 X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT APPROXIMATELY 8 ATMOSPHERES (ATM) UPON ITS THIRD INFLATION. THEREFORE, THE DEVICE WAS REMOVED; AND A NON CORDIS BALLOON CATHETER WAS USED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, 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. THE LESION WAS NOT CALCIFIED, MILDLY TORTUOUS AND 80 PERCENT STENOSED. THE DEVICE WAS NOT USED FOR A TOTAL CHRONIC OCCLUSION. INITIALLY, THE BALLOON WAS DELIVERED TO THE TARGET LESION IN THE JUXTA-ANASTOMOSIS OF AN ARTERIO-VENOUS FISTULA WITHOUT INCIDENT AND INFLATED THE BALLOON TWICE TO RATED BURST PRESSURE (RBP) OF 20 (ATM). THE BALLOON PERFORMED AS EXPECTED, BUT WITH RESIDUAL STENOSIS; THE PHYSICIAN ATTEMPTED TO INFLATE AT THIRD TIME AT WHICH POINT THE BALLOON RUPTURED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10881483 ↗
• MalfunctionOct 28, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 6MM X 4MM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS LEAKING CONTRAST AS SOON AS THEY WERE INFLATED AT A LOW-PRESSURE INFLATION. THEREFORE, THEY HAD TO USE ANOTHER POWERFLEX EXTREME PTA BALLOON OF THE SAME SIZE, IDENTICAL TO THE ONE THAT RUPTURED, AND THE SAME ISSUE HAPPENED. THE DEVICES HAD BOTH RUPTURED. THE DOCTOR DID NOT USE ANOTHER CORDIS BALLOON AFTER. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS AT THE FISTULA. THE LESION HAD NO CALCIFICATION AND NO VESSEL TORTUOSITY. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICES WERE TAKEN OUT OF THE PACKAGE. THE DEVICES WERE NOT PULLED FROM THE PACKAGING BY THE HUB AND THERE WERE NO ANOMALIES NOTED AT THIS TIME. THE DEVICES WERE PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE BALLOON CATHETERS. THERE WAS NO DIFFICULTY ENCOUNTERED CONNECTING THE HUB TO THE INDEFLATOR DEVICE. THE INDEFLATOR USED WAS A NON-CORDIS DEVICE. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETERS THROUGH THE VESSEL. THE CATHETER WAS NOT TORQUED AGAINST RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10748252 ↗
• MalfunctionOct 28, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 6MM X 4MM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS LEAKING CONTRAST AS SOON AS THEY WERE INFLATED AT A LOW-PRESSURE INFLATION. THEREFORE, THEY HAD TO USE ANOTHER POWERFLEX EXTREME PTA BALLOON OF THE SAME SIZE, IDENTICAL TO THE ONE THAT RUPTURED, AND THE SAME ISSUE HAPPENED. THE DEVICES HAD BOTH RUPTURED. THE DOCTOR DID NOT USE ANOTHER CORDIS BALLOON AFTER. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS AT THE FISTULA. THE LESION HAD NO CALCIFICATION AND NO VESSEL TORTUOSITY. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICES WERE TAKEN OUT OF THE PACKAGE. THE DEVICES WERE NOT PULLED FROM THE PACKAGING BY THE HUB AND THERE WERE NO ANOMALIES NOTED AT THIS TIME. THE DEVICES WERE PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE BALLOON CATHETERS. THERE WAS NO DIFFICULTY ENCOUNTERED CONNECTING THE HUB TO THE INDEFLATOR DEVICE. THE INDEFLATOR USED WAS A NON-CORDIS DEVICE. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETERS THROUGH THE VESSEL. THE CATHETER WAS NOT TORQUED AGAINST RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10748247 ↗
• MalfunctionOct 26, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON OF 6X4 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. A SECOND POWERFLEX EXTREME PTA BALLOON WAS USED; HOWEVER, IT ALSO LEAKED AND WOULD NOT INFLATE TO ITS NOMINAL PRESSURE. THEREFORE, ANOTHER UNKNOWN BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. BOTH BALLOONS WERE 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 PRODUCTS 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 PRODUCTS INTO THE PATIENT. THE DEVICES PREPPED NORMALLY. THE BALLOONS WERE ADVANCED OVER THE WIRE IN PATIENT. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOONS THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734136 ↗
• MalfunctionOct 26, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON OF 6X4 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. A SECOND POWERFLEX EXTREME PTA BALLOON WAS USED; HOWEVER, IT ALSO LEAKED AND WOULD NOT INFLATE TO ITS NOMINAL PRESSURE. THEREFORE, ANOTHER UNKNOWN BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. BOTH BALLOONS WERE 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 PRODUCTS 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 PRODUCTS INTO THE PATIENT. THE DEVICES PREPPED NORMALLY. THE BALLOONS WERE ADVANCED OVER THE WIRE IN PATIENT. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOONS THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734080 ↗
• MalfunctionOct 19, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER LEAKED UNKNOWN CONTRAST WHEN TRYING TO INFLATE INSIDE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN THE PATIENT. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FIELD. THE INTENDED PROCEDURE WAS A FISTULAGRAM. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, REMOVING THE STYLET, OR REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE PREPPED NORMALLY. THE DEVICE WAS PREPPED WITH A 50/50 CONTRAST/SALINE SOLUTION AND A NON CORDIS INDEFLATOR WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE PLUNGER DID DEPRESS INTO THE INDEFLATOR WHEN TRYING TO INFLATE. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE LEAKAGE WAS NOTED AT THE WIRE EXIT SITE NEAR THE BALLOON. THE MAX INFLATION PRESSURE WAS 4ATMS. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED EASILY. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701189 ↗
• MalfunctionOct 6, 2020Leak/Splash; Leak/Splash

  AS REPORTED, WHEN THE BALLOON OF A 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INSERTED INTO THE PATIENT, A LEAK WAS NOTICED UPON INFLATION. THE BALLOON WOULD NOT INFLATE TO NOMINAL PRESSURE. THEREFORE, ANOTHER UNKNOWN BALLOON WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON WAS NORMALLY PREPPED USING 50/50 UNKNOWN CONTRAST TO SALINE RATIO. THE OPERATOR WAS TRAINED TO THE POWERFLEX EXTREME DEVICE. THE DEVICE WAS OPENED IN STERILE FILED. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). 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 INTO THE PATIENT. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638108 ↗
• MalfunctionSep 24, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF 6MM 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 WAS ADVANCED OVER THE UNKNOWN WIRE INTO VESSEL. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON 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 ROTATING HEM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580853 ↗
• MalfunctionSep 24, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF THE TWO (2) 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER MINIMALLY INFLATED AND LEAKED UNKNOWN CONTRAST. THEREFORE, THE BALLOONS WERE REMOVED, AND ANOTHER UNKNOWN BALLOON WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOONS ADVANCED OVER THE UNKNOWN WIRE INTO 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 DEVICES WERE 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 RO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580792 ↗
• MalfunctionSep 24, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF THE TWO (2) 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER MINIMALLY INFLATED AND LEAKED UNKNOWN CONTRAST. THEREFORE, THE BALLOONS WERE REMOVED, AND ANOTHER UNKNOWN BALLOON WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOONS ADVANCED OVER THE UNKNOWN WIRE INTO 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 DEVICES WERE 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 RO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580784 ↗
• MalfunctionSep 11, 2020Leak/Splash; Leak/Splash

  A PINHOLE WAS NOTED ON THE BALLOON OF 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC). THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A NON-CORDIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522017 ↗
• MalfunctionSep 8, 2020Leak/Splash; Leak/Splash

  A PINHOLE WAS NOTED ON THE BALLOON OF 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC). THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A NON-CORDIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10504574 ↗
• MalfunctionSep 8, 2020Leak/Splash; Leak/Splash

  A PINHOLE WAS NOTED ON THE BALLOON OF 6MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC). THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A NON-CORDIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10503457 ↗

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