POWERFLEX 4205020TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032004203), received between Feb 27, 2018 and Feb 27, 2018 — 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. 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.

• MalfunctionFeb 27, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, A POWER FLEX P3 WAS DELIVERED TO THE STENOSED ANASTOMOTIC PART, HOWEVER IT RUPTURED AT TEN ATMOSPHERE (10 ATM). THERE WAS NO REPORTED PATIENT INJURY. THEREFORE IT WAS REPLACED WITH A SAME SIZE UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS THE RADIAL VEIN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7299150 ↗

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