POWERFLEX 4205040TRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032004265), received between Jan 31, 2019 and Jul 8, 2020 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 5F 5X4 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) HAD RUPTURED WITHIN ITS NOMINAL PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT¿S BODY. THEREFORE, IT WAS REPLACED WITH A NEW POWERFLEX P3 (DIFFERENT LOT NUMBER) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT ANASTAMOSIS PTA CASE. THE VESSEL LEVEL OF CALCIFICATION IS MODERATE. THE VESSEL LEVEL OF ANGULATION AND TORTUOSITY IS NONE. THE DEVICE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE DEVICE WAS USED IN CONJUNCTION WITH A 5F NON-CORDIS HIGH FLOW SHEATH AND ANOTHER 3CM NON-CORDIS SHEATH DURING THE PROCEDURE. THE BALLOON INFLATED NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS 4-ATMOSPHERES PRESSURE (ATM). THERE WERE NO KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED DUE TO SUSPICION OF AN INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10245220 ↗
• MalfunctionMay 13, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 5F 5X4 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED AND INFLATED SLOWLY BUT HAD RUPTURED AT LESS THAN 10 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS AT THE ARTERIAL ANASTOMOSIS AVF. THERE WAS NO CALCIFICATION NOTED AT THE LESION. THE VESSEL HAS NO TORTUOSITY AND THERE WAS 30% OF STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED AS PER INSTRUCTION FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR TO ITS 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 BY MAINTAINING NEGATIVE PRESSURE. A NON-CORDIS CONTRAST MEDIA WAS USED IN THE PROCEDURE WITH A 50:50 RATIO TO SALINE. THE INDEFLATOR WAS USED AND IT WAS THE SAME INDEFLATOR USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHETER. THE DEVICE WAS NEVER IN AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10052068 ↗
• MalfunctionMay 4, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 5F 5X4 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED AND HELD AT 12 ATMOSPHERES (ATM) HAD RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS AT THE JUXTA ANASTOMOSIS (JA) SEGMENT CEPHALIC VEIN IN ARTERIOVENTRICULAR FISTULA (AVF). THERE WAS NO CALCIFICATION NOTED AT THE LESION. THE VESSEL HAS NO TORTUOSITY AND THERE WAS 50% OF STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED AS PER INSTRUCTION FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR TO ITS 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 BY MAINTAINING NEGATIVE PRESSURE. A NON-CORDIS CONTRAST MEDIA WAS USED IN THE PROCEDURE WITH A 50:50 RATIO TO SALINE. THE INDEFLATOR WAS USED AND IT WAS THE SAME INDEFLATOR USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021551 ↗
• MalfunctionApr 6, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5F 5MM X 4MM X 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT TO BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928949 ↗
• MalfunctionDec 27, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5F 5 X 4 MM X 40 CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS INFLATED IN THE ANATOMIC PART WITH STENOSIS HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THE PROCEDURE COMPLETED USING A NEW NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE INTENDED PROCEDURE WAS ANASTOMOTIC STENOSIS WHICH HAS SEVERE ACUTE ANGULATION. THE LESION HAD NINETY NINE PERCENT OF STENOSIS AND NO CALCIFICATION. 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 NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE CATHETER WAS PASSED WITH FINGER SUPPORT FROM THE BODY SURFACE. THE CONTRAST TO SALINE RATIO WAS 1:1. A CORDIS INDEFLATOR WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9524551 ↗
• MalfunctionJan 31, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS DELIVERED TO THE LESION, HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. NO PATIENT INJURY WAS REPORTED. THIS WAS A SHUNT PTA CASE. THE LESION WAS THE ANATOMIC PART WITH STENOSIS. A NON-CORDIS SHEATH AND NON-CORDIS GUIDEWIRE WERE USED. AFTER THE POWERLFEX PRO BALLOON RUPTURED, IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW UNKNOWN BALLOON CATHETER. THE PATIENT HAD AN INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8294226 ↗

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