Reported Jul 21, 2021 · Terminated

Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring…

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?

  • Avanti¿+ Catheter
  • Sheath Introducer - Product UsageIs indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices
Lot codes and dates
  • Catalog504-657A
  • Lot 17919780Exp
  • Date 12/31/2022 and Lot 17988227Exp. Date 10/31/2023
Amount recalled
680 units

Where it was sold

Why it was recalled

The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

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 Feb 16, 2023 · Data as of Sep 19, 7:37 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.