POWERFLEX 4155040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 20705032001684), received between Jan 6, 2020 and Apr 20, 2021 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2021Leak/Splash; Leak/Splash

  WHEN PERFORMING A SHUNT PROCEDURE, THE BALLOON OF THREE (3) 5MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE INFLATED; HOWEVER, THE BALLOONS WERE BLOWN, AND 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 DEVICES WILL BE RETURNED FOR EVALUATION, ALONG WITH ALL OTHER UNUSED BALLOON CATHETERS IN STOCK. ADDENDUM: DURING THE PRODUCT ANALYSIS OF THE UNUSED BALLOON CATHETERS RETURNED, IT WAS NOTED THAT A TOTAL OF 4 ADDITIONAL DEVICES HAD A SHAFT AND/OR BALLOON LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695606 ↗
• MalfunctionApr 20, 2021Leak/Splash; Leak/Splash

  WHEN PERFORMING A SHUNT PROCEDURE, THE BALLOON OF THREE (3) 5MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE INFLATED; HOWEVER, THE BALLOONS WERE BLOWN, AND 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 DEVICES WILL BE RETURNED FOR EVALUATION, ALONG WITH ALL OTHER UNUSED BALLOON CATHETERS IN STOCK. ADDENDUM: DURING THE PRODUCT ANALYSIS OF THE UNUSED BALLOON CATHETERS RETURNED, IT WAS NOTED THAT A TOTAL OF 4 ADDITIONAL DEVICES HAD A SHAFT AND/OR BALLOON LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695519 ↗
• MalfunctionApr 20, 2021Leak/Splash; Leak/Splash

  WHEN PERFORMING A SHUNT PROCEDURE, THE BALLOON OF THREE (3) 5MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE INFLATED; HOWEVER, THE BALLOONS WERE BLOWN, AND 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 DEVICES WILL BE RETURNED FOR EVALUATION, ALONG WITH ALL OTHER UNUSED BALLOON CATHETERS IN STOCK. ADDENDUM: DURING THE PRODUCT ANALYSIS OF THE UNUSED BALLOON CATHETERS RETURNED, IT WAS NOTED THAT A TOTAL OF 4 ADDITIONAL DEVICES HAD A SHAFT AND/OR BALLOON LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695461 ↗
• MalfunctionApr 20, 2021Leak/Splash; Leak/Splash

  WHEN PERFORMING A SHUNT PROCEDURE, THE BALLOON OF THREE (3) 5MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE INFLATED; HOWEVER, THE BALLOONS WERE BLOWN, AND 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 DEVICES WILL BE RETURNED FOR EVALUATION, ALONG WITH ALL OTHER UNUSED BALLOON CATHETERS IN STOCK.ADDENDUM: DURING THE PRODUCT ANALYSIS OF THE UNUSED BALLOON CATHETERS RETURNED, IT WAS NOTED THAT A TOTAL OF 4 ADDITIONAL DEVICES HAD A SHAFT AND/OR BALLOON LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695349 ↗
• MalfunctionFeb 3, 2021Burst Container or Vessel; Burst Container or Vessel

  WHEN PERFORMING A SHUNT PROCEDURE, THE BALLOON OF A 5MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED; HOWEVER, THE BALLOON WAS BLOWN, AND 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 EVALUATION AS IT WAS ALREADY DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11271469 ↗
• MalfunctionFeb 3, 2021Burst Container or Vessel; Burst Container or Vessel

  WHEN PERFORMING A SHUNT PROCEDURE, THE BALLOON OF A 5MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED; HOWEVER, THE BALLOON WAS BLOWN, AND 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 EVALUATION AS IT WAS ALREADY DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11271452 ↗
• MalfunctionFeb 2, 2021Burst Container or Vessel; Burst Container or Vessel

  WHEN PERFORMING A SHUNT PROCEDURE, THE BALLOON OF THREE (3) 5MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE INFLATED; HOWEVER, THE BALLOONS WERE BLOWN, AND 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 DEVICES WILL BE RETURNED FOR EVALUATION, ALONG WITH ALL OTHER UNUSED BALLOON CATHETERS IN STOCK. ADDENDUM: DURING THE PRODUCT ANALYSIS OF THE UNUSED BALLOON CATHETERS RETURNED, IT WAS NOTED THAT A TOTAL OF 4 ADDITIONAL DEVICES HAD A SHAFT AND/OR BALLOON LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11265990 ↗
• MalfunctionFeb 2, 2021Burst Container or Vessel; Burst Container or Vessel

  WHEN PERFORMING A SHUNT PROCEDURE, THE BALLOON OF THREE (3) 5MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE INFLATED; HOWEVER, THE BALLOONS WERE BLOWN, AND 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 DEVICES WILL BE RETURNED FOR EVALUATION, ALONG WITH ALL OTHER UNUSED BALLOON CATHETERS IN STOCK. ADDENDUM: DURING THE PRODUCT ANALYSIS OF THE UNUSED BALLOON CATHETERS RETURNED, IT WAS NOTED THAT A TOTAL OF 4 ADDITIONAL DEVICES HAD A SHAFT AND/OR BALLOON LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11265930 ↗
• MalfunctionFeb 2, 2021Burst Container or Vessel; Burst Container or Vessel

  WHEN PERFORMING A SHUNT PROCEDURE, THE BALLOON OF THREE (3) 5MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE INFLATED; HOWEVER, THE BALLOONS WERE BLOWN, AND 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 DEVICES WILL BE RETURNED FOR EVALUATION, ALONG WITH ALL OTHER UNUSED BALLOON CATHETERS IN STOCK.ADDENDUM: DURING THE PRODUCT ANALYSIS OF THE UNUSED BALLOON CATHETERS RETURNED, IT WAS NOTED THAT A TOTAL OF 4 ADDITIONAL DEVICES HAD A SHAFT AND/OR BALLOON LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11265871 ↗
• MalfunctionSep 24, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF THE TWO (2) 5MM 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 10580939 ↗
• MalfunctionSep 24, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF THE TWO (2) 5MM 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 TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580919 ↗
• 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 5 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 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 BEEN HAVING ONGOING ISSUES WITH THIS PRODUCT. THIS EVENT HAPP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370142 ↗
• 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 5 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 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 BEEN HAVING ONGOING ISSUES WITH THIS PRODUCT. THIS EVENT HAPP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370107 ↗
• MalfunctionJul 27, 2020Leak/Splash; Leak/Splash

  AS REPORTED, A BALLOON OF A 5MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT INFLATE AND CONTRAST WAS LEAKED. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZE POWERFLEX BALLOON CATHETER HOWEVER, THE BALLOON WOULD NOT INFLATE AND LEAKED. THEREFORE, A THIRD UNKNOWN BALLOON CATHETER WAS USED TO FINISH THE CASE. THERE WAS NO PATIENT INJURY. BOTH BALLOON CATHETERS WERE PREPPED AND OPENED IN A STERILE FIELD. BALLOON CATHETERS WERE INSERTED INPATIENT. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, OR THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAINED 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 HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY ADVANCING TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10326416 ↗
• MalfunctionJul 27, 2020Leak/Splash; Leak/Splash

  AS REPORTED, A BALLOON OF A 5MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT INFLATE AND CONTRAST WAS LEAKED. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZE POWERFLEX BALLOON CATHETER HOWEVER, THE BALLOON WOULD NOT INFLATE AND LEAKED. THEREFORE, A THIRD UNKNOWN BALLOON CATHETER WAS USED TO FINISH THE CASE. THERE WAS NO PATIENT INJURY. BOTH BALLOON CATHETERS WERE PREPPED AND OPENED IN A STERILE FIELD. BALLOON CATHETERS WERE INSERTED INPATIENT. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, OR THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAINED 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 HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY ADVANCING TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10326411 ↗
• MalfunctionJul 8, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MM X 40MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED UPON FIRST INFLATION AT 15 ATMOSPHERES (ATM) WHILE ATTEMPTING TO DILATE A LESION IN AN ARTERIAL ANASTOMOSIS. THE BALLOON WAS REMOVED INTACT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PREPPED AS PER THE INSTRUCTION FOR USE (IFU). THE BALLOON WAS DELIVERED WITHOUT INCIDENT. THE DEVICE WAS STORED AND HANDLED 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 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 BALLOON INFLATED NORMALLY. THE BALLOON WAS REMOVED INTACT. AN UNKNOWN CORDIS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10246595 ↗
• MalfunctionMay 29, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE 5 X 4 80CM POWERFLEX EXTREME COULD NOT INFLATE UPON INITIAL USE BECAUSE OF THE LEAKAGE THAT WAS NOTED TO BE COMING FROM THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING AND WAS OPENED IN STERILE FIELD. THE INTENDED PROCEDURE WAS A/V FISTULOGRAM. THE LESION WAS NOT CALCIFIED AND WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE 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 DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE CONTRAST MEDIA WAS NON-CORDIS. THE CONTRAST TO SALINE RATIO WAS 50/50. 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. THERE WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10101438 ↗
• MalfunctionMay 11, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE 5MM X 4MM 80CM AND 10MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS COULD NOT INFLATE UPON INITIAL USE. THE DOCTOR WOULD INFLATE THE BALLOON AND THE BALLOON WOULD NOT RETAIN PRESSURE BECAUSE IT WOULD LEAK FROM THE TIP. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS ANGIOPLASTY IN THE OUTFLOW STENT AT THE SUBCLAVIAN VEIN. THE LESION WAS NOT CALCIFIED, HAD NO VESSEL TORTUOSITY, HAD STENOSIS OF 50% AT OUTFLOW STENT AND 90% AT SUBCLAVIAN VEIN. THE DEVICES WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE PRODUCTS WERE STORED AS PER LABELING AND WERE OPENED IN STERILE FIELD. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICES WERE NOT PREPPED NORMALLY AS LEAKAGE WAS NOTED AT THE TIP OF THE BALLOON. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. A NON-CORDIS CONTRAST WAS USED. THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10044215 ↗
• MalfunctionMar 19, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM X4CM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING FIRST INFLATION AT APPROXIMATELY 8 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS ANGIOPLASTY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). 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 CATHETER WAS NEVER IN ACUTE BEND. THE DEVICE WAS PREPPED NORMALLY. A NON-CORDIS CONTRAST MEDIA WAS USED WITH THE 50% CONTRAST TO SALINE. A NON-CORDIS 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 HEMOSTATIC VALVE. THE TARGET LESION WAS THE CEPHALIC VEIN. THE LESION WAS NOT CALCIFIED, HAD NO VESSEL TORTUOSITY, HAD 80% OF STENOSIS, AND NOT A CHRONIC TOTAL OCCLUSION. THERE WAS NO RESISTANC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9853240 ↗
• MalfunctionJan 6, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MMX40MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED AT BURST PRESSURE OF 20 ATMOSPHERES (ATM) WHEN ATTEMPTING TO CRACK THE LESION IN THE BRACHIOCEPHALIC VEIN. THE BALLOON WAS INFLATED TO RBP TRICE HOWEVER, IT RUPTURED ON ITS FOURTH INFLATION. THEREFORE, THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICES PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVERS. 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. A NON-CORDIS CONTRAST MEDIA WAS USED WITH A 50% SALINE RATIO. A NON-CORDIS INFLATION DEVICE WAS USED IN THE PROCEDURE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554410 ↗
• MalfunctionJan 6, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MMX40MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED AT BURST PRESSURE OF 20 ATMOSPHERES (ATM) WHEN ATTEMPTING TO CRACK THE LESION IN THE BRACHIOCEPHALIC VEIN. THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE TWICE AND IT RUPTURED. THEREFORE, THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICES PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVERS. 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. A NON-CORDIS CONTRAST MEDIA WAS USED WITH A 50% SALINE RATIO. A NON-CORDIS INFLATION DEVICE WAS USED IN THE PROCEDURE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553279 ↗

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