FDAFDA · Food and drugs·Recall number Z-0528-2015
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The 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.
Published December 17, 2014 · Recall initiated: November 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Concentric Medical Inc
- Distributor
- US Distribution to states of: CA, IN, PA, AL, and NJ.
- Lot
- Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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