Z-0528-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2014
- Initiation Date
- November 13, 2013
- Termination Date
- December 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
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.
Reason for Recall
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
Distribution Pattern
US Distribution to states of: CA, IN, PA, AL, and NJ.
Code Information
Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015