Reported Jun 24, 2020 · Terminated

Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus…

Abbott Vascular

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: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630

Is this the product you have?

  • Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm
  • x 33mmStrength100 ¿g/cm¿
  • Nominal Everolimus Content
    • 209 ¿g
    • Lot number 903224A
Lot codes and dates
  • Lot Number
    • 903224A
    • Device Identifier/GTIN 08717648227455
Amount recalled
13 units

Where it was sold

Why it was recalled

Incorrect expiration date

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 Jul 12, 2021 · Data as of Sep 19, 4:49 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.