POWERFLEX 4158040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20705032001943), received between Dec 2, 2016 and Mar 8, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 8MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 15 ATMOSPHERES (ATM). A SECOND 8MM X 40MM 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 A GREATER THAN 70% STENOSED FISTULA LESION WHICH HAD MODERATE CALCIFICATION BUT NO SIGNS OF TORTUOSITY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. AN 80% SALINE AND 20% CONTRAST MIXTURE WAS USED TO PREP THE DEVICE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865203 ↗
• MalfunctionDec 9, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE POWERFLEX EXTREME 8X4 TRACKED OVER THE UNKNOWN WIRE TO DESIRED LESION. HOWEVER, THE BALLOON WOULD NOT INFLATE TO NOMINAL AND CONTRAST LEAKAGE WAS NOTICED IN THE VESSEL FROM THE BALLOON. THE LEAK WAS NOTICED AT 1 ATM. THIS WAS NOTICED DURING POSITIVE PRESSURE. THE DEVICE WAS REMOVED AND DISCARDED. THE CASE WAS COMPLETED WITH THE USE OF AN ADDITIONAL POWERFLEX EXTREME BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, 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 OPENED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOTED TO HAVE MAINTAINED NEGATIVE PRESSURE. 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 ADVANCING THROUGH THE VESSEL. THERE WAS NO DIFFICULTY ADVANCING THROUGH THE LESION. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15952054 ↗
• MalfunctionMay 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED, DURING THE INFLATION OF AN 8MM X 4CM 80CM POWERFLEX EXTREME, THERE WAS A LEAKAGE OBSERVED IMMEDIATELY AT THE DISTAL BALLOON TIP. AS A RESULT, ANOTHER 8MM X 40MM CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN ANGIOPLASTY PROCEDURE TO TREAT A LESION WHICH HAD NO SIGNS OF CALCIFICATION OR TORTUOSITY AND WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS DURING PREPARATION OF THE DEVICE, AND THERE WERE NO KINKS OR DAMAGES OBSERVED PRIOR TO USING THE DEVICE. THE BALLOON WAS PREPPED WITH A 50% CONTRAST AND 50% SALINE MIXTURE. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED DURING THE INSERTION OF THE DEVICE. THE BALLOON CATHETER WAS ABLE TO TRACK TOWARD THE LESION AND CROSS THE LESION WITHOUT DIFFICULTY. ADDITIONALLY, THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND AND DID NOT KINK DURING ITS USE. AFTER THE LEAKAGE OCCURRED, THE BALLOON CATHETER WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. INFORMATION REGARDING THE PATIENT, THE TARGET LESION,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345184 ↗
• MalfunctionMay 3, 2022Leak/Splash; Leak/Splash

  AS REPORTED, DURING INFLATION OF AN 8MM X 4CM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WITH A SYRINGE, THE BALLOON WAS MINIMALLY INFLATED, AND A LEAKAGE OF CONTRAST WAS OBSERVED COMING FROM THE BALLOON. AS A RESULT, THE 8MM X 4CM 80CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS REMOVED, AND A NEW 8MM X 4CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A PROCEDURE TO TREAT AN A/V FISTULA LESION IN WHICH AN UNKNOWN GUIDEWIRE WAS USED. THE 8MM X 4CM 80CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS PREPPED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU), A 50/50 SALINE AND CONTRAST MIXTURE WAS USED TO PREP THE BALLOON OF THE 8MM X 4CM 80CM POWERFLEX EXTREME, AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE POWERFLEX EXTREME PTA BALLOON CATHETER FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, ANY OF THE STERILE PACKAGING COMPONENTS, AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14271666 ↗
• MalfunctionApr 28, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 8MM X 4CM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION TO 10 ATMOSPHERES (ATM). AS A RESULT, THE 8MM X 4CM 80CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS REMOVED, AND A 9MM X 4CM 80CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN INTERVENTIONAL PROCEDURE TO TREAT A 90% FOCAL STENOSIS OF THE PROXIMAL CEPHALIC VEIN. THE TARGET LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO) AND THERE WAS NO CALCIFICATION OR TORTUOSITY PRESENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREP THE BALLOON WHICH MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED AS THE 8MM X 4CM 80CM POWERFLEX EXTREME WAS INSERTED INTO THE PATIENT. THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14237450 ↗
• MalfunctionApr 27, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 8MM X 4CM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS FIRST INTRASTENT INFLATION. AS A RESULT, A 9MM X 40MM NON-CORDIS BALLOON CATHETER WAS USED IN PLACE OF THE 8MM X 4CM 80CM POWERFLEX EXTREME PTA WITHOUT ISSUE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED STENT AT THE VENOUS ANASTOMOSIS. THE LESION HAD MILD CALCIFICATION, AN 80% STENOSIS, AND WAS NON A CHRONIC TOTAL OCCLUSION (CTO). IT WAS ALSO REPORTED THAT THERE WAS NO TORTUOSITY TO THE TARGET VESSEL. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THE BALLOON WAS PREPPED WITH A 50/50 CONTRAST AND SALINE MIXTURE. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED WHILE INSERTING THE DEVICE. THERE WAS NO DIFFICULTY TRACKING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14221688 ↗
• MalfunctionJan 6, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8 X 4 X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 14 ATMOSPHERES (ATM) UPON INITIAL INFLATION. THE DEVICE WAS REMOVED INTACT AND A NON CORDIS PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELLING. THE LESION WAS NOT CALCIFIED NOR TORTUOUS AND WAS 75 PERCENT STENOSED. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES 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. GE OMNIPAQUE CONTRAST MEDIA WAS USED AT A 50/50 CONTRAST TO SALINE RATIO. A NON CORDIS INFLATION DEVICE WAS USED AND 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 BAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124792 ↗
• MalfunctionOct 26, 2020Leak/Splash; Leak/Splash

  DURING USE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON OF 8X4 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 10734263 ↗
• MalfunctionSep 24, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF 8MM 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 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 HEMOSTATIC VALVE, OR WHIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10579606 ↗
• MalfunctionApr 17, 2020Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, THE STERILE POUCH OF AN 8MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS NEVER SEALED AT THE BOTTOM. THERE WAS NO REPORTED PATIENT INJURY. THE POUCH WAS NOT PREVIOUSLY OPENED. THE PACKAGING HAD NOT BEEN DAMAGED. THE PACKAGE WAS NOT OPENED FOR A PATIENT AND IT WAS NOTICED BEFORE EVER NEEDING TO BE USED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IMAGES WERE AVAILABLE FOR REVIEW. IMAGE 1 WAS REVIEWED. UPON REVIEW, IT APPEARS THE SEAL IS MISSING FROM AN UNKNOWN INNER PACKAGE. IMAGE 2 WAS REVIEWED. UPON REVIEW, THIS APPEARS TO BE AN IMAGE OF WHAT THE SEAL IS SUPPOSED TO LOOK LIKE, OR POSSIBLY SHOWING THE OTHER END OF THE PACKAGING IS AS IT SHOULD BE. IMAGE 3 WAS REVIEWED. UPON REVIEW, THIS IS A PHOTO OF A POWERFLEX EXTREME LABEL WITH THE DEVICE IN ITS ORIGINAL PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9972587 ↗
• MalfunctionJun 12, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING INITIAL INFLATION OF AN IN STENT DILATION, THE 8 X 40 MM POWERFLEX EXTREME BALLOON CATHETER RUPTURED AT EIGHTEEN RATE BURST PRESSURE (18 ATMS). THERE WAS NO PATIENT INJURY. A COMPETITOR'S BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE BALLOON WAS REMOVED FROM THE PATIENT AND INSPECTED. CONTRAST WAS USED TO VERIFY THAT THERE WERE NO REMAINING PIECES LEFT IN THE PATIENT. THE EXAM WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THE TARGET LESION IS THE CEPHALIC ARCH WHICH WAS EIGHTY PERCENT (80%) STENOSIS. THE USER FEELS THAT THE STENT MAY HAVE CAUSED THE BALLOON TO RUPTURE. THE DEVICE WAS PREP ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO DIFFICULTY NOTED. 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 CONTRAST MEDIA AND INFLATION DEVICE WAS USED WITH AN ONE TO ONE RATIO. 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. THER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692522 ↗
• MalfunctionMay 7, 2019Leak/Splash; Leak/Splash

  AS REPORTED, WHILE ATTEMPTING TO INFLATE THE 8X4 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DEVICE IN THE CEPHALIC VEIN, CONTRAST WAS OBSERVED TO BE LEAKING OUT FROM THE BALLOON. THE BALLOON WAS REMOVED INTACT AND INSPECTED OUTSIDE OF THE PATIENT. CONTRAST WAS OBSERVED TO BE LEAKING FROM THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE POWERFLEX WAS ATTEMPTED TO BE USED DURING AN ANGIOPLASTY PROCEDURE. THE LESION WAS NOT CALCIFIED, HAD NO TORTUOSITY, WAS NOT A CHRONIC TOTAL OCCLUSION (CTO), BUT HAD A RATE OF STENOSIS OF 90%. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS, THE PRODUCT FROM THE HOOP, OR THE PROTECTIVE BALLOON COVER. THE DEVICE WAS PREPPED PER THE IFU AND PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). THE CONTRAST TO SALINE RATIO WAS 50% CONTRAST 50% NORMAL SALINE. THE MERIT INDEFLATOR 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. THERE WAS NO DIFFICULTY ADVANCING THE B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8585846 ↗
• MalfunctionDec 2, 2016Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN 8 X 40 MM POWERFLEX EXTREME PTA DILATATION CATHETER WAS INFLATED IN A CEPHALIC VEIN TO 18 ATM, THEN REPOSITIONED AND INFLATED ONCE MORE TO 20 ATM WHEN IT RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-CORDIS PTA DILATATION CATHETER. THERE WERE NO PATIENT INJURIES. THE BALLOON WAS SAFELY REMOVED FROM THE PATIENT, AND THERE WAS NO FURTHER INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-CORDIS PTA DILATATION CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6142874 ↗

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