Reported Mar 18, 2020 · Terminated

Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

Cordis Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cordis Corporation · 14201 NW 60th Ave · Miami Lakes, FL · 33014-2802

Is this the product you have?

    • Cordis POWERFLEX P3
    • PTA Dilation Catheter
    • REF 420-6020S
Lot codes and dates
    • Lot 82155955
    • Use by date 2021-06-30
Amount recalled
89 units

Why it was recalled

Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 13, 2023 · Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.