POWERFLEX 4207000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032004517), received between Jul 11, 2022 and Jul 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 10CM 80CM POWERFLEX P3 F5 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING ITS NOMINAL PRESSURE. AS A RESULT, A NEW 7MM X 10CM 80CM POWERFLEX P3 BALLOON CATHETER WAS USED IN PLACE OF THE 7MM X 10CM 80CM POWERFLEX P3 PTA BALLOON CATHETER AND WAS USED WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A FISTULA LESION WHICH HAD AN 80% STENOSIS BUT SHOWED NO SIGNS OF CHRONIC TOTAL OCCLUSION (CTO), CALCIFICATION, OR TORTUOSITY. A NON-CORDIS .035 GUIDEWIRE WAS USED FOR THE PROCEDURE WITHOUT ISSUE. 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. THERE WAS NO RESISTANCE OR FRICTION DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO TRACK TOWARD THE LESION AND CROSS THE LESION WITHOUT DIFFICULTY. THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND AND DID NOT KI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976318 ↗

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