POWERFLEX 4204040TRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032004098), received between Feb 22, 2018 and Jul 26, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (9 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.

• MalfunctionJul 26, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4MM X 4CM X 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED, HOWEVER, IT RUPTURED WHEN IT CROSSED THE CALCIFICATION PART. THE PROCEDURE WAS COMPLETED USING ANOTHER UNKNOWN DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN THE STERILE FIELD. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS A "VAIVT" CASE OF THE CEPHALIC VEIN. THE VESSEL HAD 50% CALCIFICATION, NO TORTUOSITY, 60% STENOSIS, AND WAS NOT A CTO. 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. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC OR 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 DID PASS THROUGH AN ACUTE BEND. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12224600 ↗
• MalfunctionJun 30, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5F 4MM X 4MM X 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH ANOTHER NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT PTA CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091950 ↗
• MalfunctionJun 8, 2021Burst Container or Vessel; Burst Container or Vessel

  A 5F 4MM X 4MM X 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED AND RUPTURED AT NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED IN THE HOSPITAL. THE TARGET VESSEL WAS THE BRACHIAL ARTERY. THE LESION WAS A LITTLE CALCIFIED AND THE VESSEL WAS ALSO A LITTLE TORTUOUS. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICE. 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 OR DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE USER ABLE TO DEPRESS THE PLUNGER INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957488 ↗
• MalfunctionFeb 12, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4MM X 40MM X 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW UNKNOWN BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11324770 ↗
• MalfunctionFeb 12, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5F 4MM X 4MM X 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED. HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT PTA CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321201 ↗
• MalfunctionDec 14, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5F 4 X 4 X 40 POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED DURING SHUNT PLASTY, BUT IT RUPTURED WITH NOMINAL PRESSURE. THE DEVICE WAS REMOVED, AND THE PATIENT WAS TREATED WITH ANOTHER BALLOON CATHETER (UNKNOWN). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER OR DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. 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. THE LESION CALCIFIED WAS A LITTLE. THE VESSEL WAS A LITTLE TORTUOUS. THERE WAS 20-30% PERCENTAGE OF STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS).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 PLUNGER WAS DEPRESSED INTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11004045 ↗
• MalfunctionMay 2, 2018Burst Container or Vessel; Difficult to Advance; Burst Container or Vessel; Difficult to Advance

  DURING USE, IT WAS REPORTED THAT THE POWERFLEX P3 RUPTURED AT EIGHT ATMOSPHERE. ADDITIONAL INFORMATION WAS RECEIVED AND THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND CROSSING THE LESION. THERE WAS NO PATIENT INJURY. THE POWERFLEX WAS REPLACED WITH ANOTHER UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED BY HIGH- PRESSURE DILATATION. THE TARGET LESION WAS THE SHUNT WHICH WAS SEVERELY CALCIFIED, MODERATELY TORTUOUS WITH NINETY PERCENT STENOSIS. THE DEVICE APPEARED TO BE NORMAL WHEN IT WAS OPENED. THERE WERE NO DIFFICULTY INFLATING THE BALLOON DURING PREP. 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. THE CONTRAST TO SALINE RATIO IS ONE TO ONE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER. THERE WAS DIFFICULTY CROSSING THE LESION. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PRODUCT REMOVED INTACT (IN ONE PI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7479571 ↗
• MalfunctionFeb 27, 2018Burst Container or Vessel; Difficult to Insert; Burst Container or Vessel; Difficult to Insert

  DURING A FISTULAGRAM IN THE THIGH, IT WAS REPORTED THAT THE POWER FLEX P3 BALLOON CATHETER (BC) WOULD NOT INFLATE BECAUSE THE BALLOON WAS BREAKING AS IT GOT CAUGHT ON PART OF THE CATHETER GRAFT. THERE WAS NO PATIENT INJURY. THE PATIENT HAD A HEROGRAFT AND THERE WAS A NARROWING WERE THEY CONNECTED. THERE WAS AN ATTEMPT TO BALLOON THE NARROWING AND THE BALLOON WOULD INFLATE FOR A SHORT TIME AND THEN BREAK. THE PHYSICIAN BELIEVES THAT THE MATERIALS OF THE GRAFT WAS SHREDDING THE BALLOONS. ONLY ONE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298965 ↗
• MalfunctionFeb 22, 2018Burst Container or Vessel; Difficult to Insert; Burst Container or Vessel; Difficult to Insert

  DURING A FISTULAGRAM IN THE THIGH, IT WAS REPORTED THAT THE POWER FLEX P3 BALLOON CATHETER (BC) WOULD NOT INFLATE BECAUSE THE BALLOON WAS BREAKING AS IT GOT CAUGHT ON PART OF THE CATHETER GRAFT. THERE WAS NO PATIENT INJURY. THE PATIENT HAD A HEROGRAFT AND THERE WAS A NARROWING WERE THEY CONNECTED. THERE WAS AN ATTEMPT TO BALLOON THE NARROWING AND THE BALLOON WOULD INFLATE FOR A SHORT TIME AND THEN BREAK. THE PHYSICIAN BELIEVES THAT THE MATERIALS OF THE GRAFT WAS SHREDDING THE BALLOONS. ONLY ONE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7290529 ↗

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