POWERFLEX 4206040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032004432), received between Feb 13, 2020 and Oct 7, 2022 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

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

  AS REPORTED, THE POWERFLEX P3 F5 6X4 BALLOON BURST DURING INFLATION. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE ATM AT WHICH THE BALLOON BURST IS UNKNOWN DUE THE PHYSICIAN USING A MEDALLION SYRINGE. THE CASE WAS COMPLETED WITH THE USE OF A NEW POWERFLEX P3 BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE BALLOON DID RUPTURE WHILE IN THE VESSEL. THE BALLOON DID NOT RUPTURE WHILE IN A STENT. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED ON THE DEVICE PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE VESSEL WAS NOTED TO HAVE HAD A LITTLE TORTUOSITY AND THE LESION HAD A LITTLE CALCIFICATION. THE CASE BEING PERFORMED WAS A DIALYSIS ANGIOPLASTY. THE LESION WAS NOTED TO HAVE AN 80% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15568395 ↗
• MalfunctionSep 19, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE USE OF A 6MM X 4CM 80CM POWERFLEX P3 F5 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON WAS ¿BARELY¿ INFLATED AND RUPTURED. AS A RESULT, THE 6MM X 4CM 80CM POWERFLEX P3 WAS REMOVED, AND AN UNKNOWN 6MM X 4CM BALLOON CATHETER WAS USED SUCCESSFULLY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A FISTULA LESION. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). 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 DEVICE WAS ABLE TO CROSS THE LESION. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445414 ↗
• MalfunctionJun 13, 2022Leak/Splash; Leak/Splash

  AS REPORTED, A 5F 6X4 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WHILE INSIDE THE PATIENT SEEMED TO HAVE A HOLE IMMEDIATELY ALTHOUGH THE PHYSICIAN BARELY PUT ANY PRESSURE. A SECOND UNKNOWN BALLOON WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUE AND INJURY. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY, AND IT DID NOT APPEAR TO BE DEFORMED. THE INTENDED PROCEDURE/VESSEL WAS AN ANGIOPLASTY OF FISTULA. A NON-CORDIS SYRINGE WAS USED AS AN INFLATION DEVICE AND WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE PHYSICIAN BELIEVED THERE WAS A HOLE AS A FLUOROSCOPY IMAGE SHOWED MINIMAL INFLATION WITH CONTRAST COMING OUT. THE BALLOON INFLATED MINIMALLY AND DID NOT BURST. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681706 ↗
• MalfunctionJun 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED, A 5F 6X4 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WHILE INSIDE THE PATIENT SEEMED TO HAVE A HOLE IMMEDIATELY ALTHOUGH THE PHYSICIAN BARELY PUT ANY PRESSURE. A SECOND UNKNOWN BALLOON WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUE AND INJURY. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY, AND IT DID NOT APPEAR TO BE DEFORMED. THE INTENDED PROCEDURE/VESSEL WAS AN ANGIOPLASTY OF FISTULA. A NON-CORDIS SYRINGE WAS USED AS AN INFLATION DEVICE AND WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE PHYSICIAN BELIEVED THERE WAS A HOLE AS A FLUOROSCOPY IMAGE SHOWED MINIMAL INFLATION WITH CONTRAST COMING OUT. THE BALLOON INFLATED MINIMALLY AND DID NOT BURST. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658667 ↗
• MalfunctionSep 11, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 6 X 4 X 80 F5 POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED. THE BALLOON WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH A NON-CORDIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE MAXIMUM INFLATION PRESSURE WAS SIX ATMOSPHERES. 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, OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. A GE OMNIPAQUE CONTRAST MEDIA WAS USED WITH A 50/50 CONTRAST TO SALINE RATIO. 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 DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521688 ↗
• MalfunctionApr 7, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, TWO 6MM X 40MM 80CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS RUPTURED. THE FIRST BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) AND THE SECOND BALLOON WAS RUPTURED AT 14 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933107 ↗
• MalfunctionApr 7, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, TWO 6MM X 40MM 80CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS RUPTURED. THE FIRST BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) AND THE SECOND BALLOON WAS RUPTURED AT 14 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933090 ↗
• MalfunctionMar 31, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX P3 6MMX4CM 80CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ATTEMPTED TO BE USED HOWEVER, THE BALLOON WOULDN'T INFLATE AND IT WAS REMOVED FROM PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER POWERFLEX P3 6MMX4CM 80CM PTA BALLOON CATHETER. NO PATIENT INJURY REPORTED. THE TARGET LESION WAS A JUXTA-ANASTAMOTIC STENOSIS OF AN ARTERIOVENOUS FISTULA. THE LESION WAS MODERATELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS PREPPED PER INSTRUCTIONS FOR USE (IFU). THE DEVICE PREPPED NORMALLY. A NON-CORDIS 6F SHEATH WAS USED. THERE WAS NO RESISTANCE INSERTING THE BALLOON THROUGH THE HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. A SYRINGE WAS USED AS AN INFLATION DEVICE AND IT WAS USED SUCCESSFULLY WITH ANOTHER DEVICE. THE PLUNGER DID NOT DEPRESS INTO THE SYRINGE WHEN TRYING TO INFLATE. THE DEVICE WILL BE RETURNED FOR EVALUATION. DURING ANALYSIS OF DEVICE, A BURST WAS OBSERVED ON THE BALLOON¿S DISTAL AREA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9903558 ↗
• MalfunctionFeb 13, 2020Leak/Splash; Leak/Splash

  A 5F 6MM X 40MM X 80CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED ONE TIME AND MET ITS NOMINAL INFLATION PRESSURE, THEN LEAKED FROM THE TIP AND WOULD NOT INFLATE AGAIN WHEN TRYING TO TREAT THE LESION. THE PRODUCT WAS REMOVED INTACT IN ONE PIECE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS ANGIOGRAM DECLOTTING OF THE ARTERIOVENOUS (AV) FISTULAS. THE TARGET LESION WAS AT THE LEFT ARTERIAL UPPER ARM PRIMARILY THE AXILLARY ARTERIOVENOUS (AV) FISTULAS. THE FISTULAS WERE NOTED TO HAVE A JUXTA-ANASTOMOTIC SEGMENT (JXA) STENOSIS. THE LESION HAD MODERATE CALCIFICATION. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS STORED, HANDLED AND PREPPED AS PER THE INSTRUCTION FOR USE (IFU). THE DEVICE WAS STORED AS PER THE LABELING AND WAS OPENED IN A STERILE FIELD. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THE DEVICE WAS PREP NORMALLY AND MAINTAINED NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND FROM THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707396 ↗

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