Reported Dec 17, 2014 · Terminated
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore…
Concentric Medical 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: Concentric Medical Inc · 301 E Evelyn Ave · Mountain View, CA · 94041-1530
Is this the product you have?
Trevo Pro 4 Stent RetrieverModel number 80021U.S
- Indications for useThe Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment
- Lot codes and dates
- Lot number/Expiration dateLot
- Number 36774March 2015
- Lot Number 36432December 2014
- Lot Number 36757March 2015
- Lot Number 36761March 2015
- Amount recalled
- 10 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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