Reported Jan 10, 2024 · Completed

Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.

Medtronic Inc.

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: Medtronic Inc. · 4600 Nathan Ln N · Plymouth, MN · 55442-2890

Is this the product you have?

  • Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Lot codes and dates
    • Lot number B644679
    • UDI-DI 00643169728974
Amount recalled
1

Where it was sold

  • Nationwide
  • MN

Why it was recalled

Seal defects could compromise the ability of the product packaging to maintain sterility.

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

Data as of Sep 19, 5:44 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.