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U.S. Department of Health and Human Services

Class 2 Device Recall Distal Access Catheter

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  Class 2 Device Recall Distal Access Catheter see related information
Date Initiated by Firm September 26, 2013
Date Posted December 12, 2014
Recall Status1 Terminated 3 on December 08, 2014
Recall Number Z-0525-2015
Recall Event ID 69764
510(K)Number K110483  
Product Classification Catheter, percutaneous - Product Code DQY
Product Distal Access Catheter:
Model Numbers: 90121, 90130, 90131, 90160.

The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Code Information Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014
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		 Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated September 26, 2013 consignees/customers at all affected sites by registered mail. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately locate the subject devices and quarantine them; distribute notice to all affected departments in your facility; inform Concentric Medical (Stryker Neuovascular) 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, complete form 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 87 units
Distribution US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
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 = DQY and Original Applicant = CONCENTRIC MEDICAL, INC.
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