POWERFLEX 4400322XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032059111), received between Jun 22, 2023 and Jun 22, 2023 — classified as 1 malfunction.

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

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

• MalfunctionJun 22, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 3MM X 22CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 10 ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION. AS A RESULT, A 3MM X 15MM NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE BALLOON RUPTURED WHILE ATTEMPTING TO DILATE A CHRONIC TOTALLY OCCLUDED (CTO) ATHEROSCLEROTIC ANTERIOR TIBIAL LESION. THERE WAS NO TORTUOSITY AT THE LESION. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE BALLOON WAS PREPPED WITH A 1:1 CONTRAST TO SALINE RATIO. THE DEVICE WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183362 ↗