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U.S. Department of Health and Human Services

Class 2 Device Recall Trevo Pro 4 Stent Retriever

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  Class 2 Device Recall Trevo Pro 4 Stent Retriever see related information
Date Initiated by Firm November 13, 2013
Date Posted December 08, 2014
Recall Status1 Terminated 3 on December 08, 2014
Recall Number Z-0528-2015
Recall Event ID 69799
510(K)Number K120961  
Product Classification Catheter, thrombus retriever - Product Code NRY
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.
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 
Recalling Firm/
Manufacturer		 Concentric Medical Inc
301 E Evelyn Ave
Mountain View CA 94041-1530
For Additional Information Contact Peter Henrich
650-810-1716
Manufacturer 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 2		 Process control
Action 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.
Quantity in Commerce 10 units
Distribution US Distribution to states of: CA, IN, PA, AL, and NJ.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NRY and Original Applicant = CONCENTRIC MEDICAL, INC.
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