POWERFLEX 4205040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032004258), received between Dec 20, 2019 and Sep 22, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 40MM X 80CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. ANOTHER P3 BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT WAS STORED AS PER LABELING. THE PRODUCT LOOKED NORMAL WHEN IT WAS REMOVED FROM ITS PACKAGING. THE DEVICE PREPPED NORMALLY. THERE WAS NO DIFFICULTY REMOVING THE 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 IN A STERILE FIELD. THE DEVICE WAS USED IN PATIENT. THE SAME UNKNOWN INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THERE WERE NO OTHER ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10568397 ↗
• MalfunctionDec 20, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MMX40MM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED AT 10 ATMOSPHERES (ATM) WHILE TREATING AN ARTERIAL GRAFT ANASTOMOSIS DE-CLOT. THEREFORE, THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT WITHOUT INCIDENT AND REPLACED WITH ANOTHER POWERFLEX P3 BALLOON SUBSEQUENTLY AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE 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 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 THE PRODUCT INTO THE PATIENT. A NON-CORDIS CONTRAST MEDIA WAS USED WITH 50/50 CONTRAST TO SALINE RATIO. THE TARGET LESION WAS THE ARTERIAL GRAFT ANASTOM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9507497 ↗

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