Skip to content

POWERFLEX 4400602XRecalls & reported problems

Cordis US Corp. · POWERFLEXPRO 6MM2CM 135 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032059470), received between Jul 14, 2017 and Jul 14, 2017 — 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

Device problems

  • Burst Container or Vessel1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 14, 2017Burst Container or Vessel; Burst Container or Vessel

    AS REPORTED IN A VOLUNTARY MEDWATCH, THE POWERFLEX BALLOON CATHETER RUPTURED. THERE WERE NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6715003 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

All Catheter, angioplasty, peripheral, transluminal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.