Recall Z-0528-2015
Concentric Medical Inc · initiated November 13, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015
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.
FDA-determined cause: Process control
Action taken
The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated November 18, 2013 to all affected customers by traceable mail. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately locate the subject devices and quarantine them; distribute this notice to all affected departments in your facility; inform Concentric Medical (Stryker Neurovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via fax to: 1-866-876-4355 or email a copy to: NeuroComplaints@stryker.com, even if you do not have any subject devices to return, and keep a copy of the completed, signed Customer Response Form for your records. Should you have any queries concerning this matter, please do not hesitate to contact the QA Manager at 650-810-1716.
Details
- Recall number
- Z-0528-2015
- Initiated
- November 13, 2013
- Posted by FDA
- December 8, 2014
- Terminated
- December 8, 2014
- Product code
- NRY – Catheter, Thrombus Retriever
- Quantity
- 10 units
- Distribution
- US Distribution to states of: CA, IN, PA, AL, and NJ.
- Recalling firm
- Concentric Medical Inc, Mountain View, CA