Reported Jun 18, 2014 · Terminated

Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.

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 EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Lot codes and dates
  • Catalog # 85R30300S LOT #
  • CE0001447 exp date2014-08
Amount recalled
80 units

Where it was sold

Why it was recalled

Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

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 Jun 23, 2014 · Data as of Sep 19, 5:28 PM UTC

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