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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Launcher Coronary Guide Catheter

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  Class 2 Device Recall Medtronic Launcher Coronary Guide Catheter see related information
Date Initiated by Firm October 13, 2014
Date Posted November 13, 2014
Recall Status1 Terminated 3 on February 18, 2015
Recall Number Z-0205-2015
Recall Event ID 69488
510(K)Number K021256  
Product Classification Catheter, percutaneous - Product Code DQY
Product Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Code Information Lot Number: 0007244836 MODEL: LA6JR40K
Recalling Firm/
Manufacturer		 Medtronic Vascular
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information Contact
978-777-0042
Manufacturer Reason
for Recall		 Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the
FDA Determined
Cause 2		 Process control
Action Beginning October 13, 2014, Medtronic field representatives will being hand delivery of the customer communication to affected customers, notifying them of the issue, and requesting return of unaffected product. Customers will be asked to sign a certificate confirming they have received the notification and have taken the requested action. 1. Identify and quarantine all listed, unused product in your inventory. 2. Return all listed product in your inventory to Medtronic. Contact Customer Service at 888-283-7868 to initiate a product return and credit. Your Medtronic sales representative can assist you in the return of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and email it to RS.CFQFCA@Medtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality.
Quantity in Commerce 11 devices
Distribution US Distribution including the states of NC, IA, IL and KS.
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 = MEDTRONIC VASCULAR
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