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POWERFLEX 4400806SRecalls & reported problems

Cordis US Corp. · POWERFLEXPRO 8MM6CM 80 · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032059838), received between Mar 17, 2020 and Mar 17, 2020 — classified as 1 injury.

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.

  • InjuryMar 17, 2020Burst Container or Vessel; Burst Container or Vessel

    AS REPORTED, THE 8MM X 6CM 80 POWERFLEX PRO BALLOON CATHETER (BC) WAS FOUND THAT IT COULD NOT BE FILLED NORMALLY AFTER IT WAS OPEN FROM PACKAGING. THERE WAS NO REPORTED PATIENT INJURY. DURING PRODUCT EVALUATION, THE BALLOON LEAKAGE WAS OBSERVED DURING INFLATION TEST, RESULTS SHOWED THAT THE BALLOON BURST WAS CAUSED BY A RUPTURE ON THE BALLOON SURFACE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9845099 ↗

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.