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U.S. Department of Health and Human Services

Class 2 Device Recall 9F Pruitt F3 Outlying Carotid Shunt with Tport

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  Class 2 Device Recall 9F Pruitt F3 Outlying Carotid Shunt with Tport see related information
Date Initiated by Firm October 04, 2011
Date Posted October 19, 2011
Recall Status1 Terminated 3 on March 14, 2012
Recall Number Z-0070-2012
Recall Event ID 60007
510(K)Number K051067  
Product Classification Catheter, intravascular occluding, temporary - Product Code MJN
Product LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port

The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteries. An external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety balloon is yellow, to increase its visibility. Depth markings on the shunt body are for reference during insertion
Code Information Lot Number: PFT2209
Recalling Firm/
Manufacturer		 Lemaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact Brian Kickham
781-221-2266 Ext. 163
Manufacturer Reason
for Recall		 Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05
FDA Determined
Cause 2		 Incorrect or no expiration date
Action The firm, LeMaitre Vascular, Inc., sent an "URGENT: 9F PRUITT F3 Carotid Shunt Device Field Safety Notice" dated October 4, 2011 to its customers. The notice describes the product, problem and action to be taken. The customers were instructed to identify their inventory; return the affected products for exchange with a properly labeled device; contact Le Matire customer service for replacement at 800-628-9470, and complete and return the RECALL NOTICE RECONCILIATION FORM via fax to 781-425-5049, even if no product is on hand. If you have any questions concerning this safety notice, please contact the Quality Assurance Engineer at 781-221-2266 ext. 183.
Quantity in Commerce 144 units
Distribution Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI.
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 = MJN and Original Applicant = LEMAITRE VASCULAR, INC.
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