Device product
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.
Z-0528-2015
Product summary
- Event
- Event 69799
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0528-2015
Official wording
Reason: Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
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
Distribution pattern: US Distribution to states of: CA, IN, PA, AL, and NJ.
Derived failure modes
-
Unknown
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.