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U.S. Department of Health and Human Services

Class 2 Device Recall Guidant MultiLink RX Vision

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  Class 2 Device Recall Guidant MultiLink RX Vision see related information
Date Initiated by Firm July 16, 2007
Date Posted August 29, 2007
Recall Status1 Terminated 3 on June 14, 2011
Recall Number Z-1211-2007
Recall Event ID 39147
PMA Number P020047 
Product Classification coronary stent - Product Code MAF
Product Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951
Code Information Part number 1007848-15, lot number 7052951
Recalling Firm/
Manufacturer		 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact Seble W. Afework
408-845-3286
Manufacturer Reason
for Recall		 The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.
FDA Determined
Cause 2		 Other
Action The firm initiated the recall on 07/16/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions to work with their local account representative to review their inventory, remove the recalled product, complete the Customer Reply form and return the recalled product to Abbott Vascular.
Quantity in Commerce 43 units
Distribution Nationwide
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.
PMA Database PMAs with Product Code = MAF and Original Applicant = ABBOTT VASCULAR
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