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U.S. Department of Health and Human Services

Class 2 Device Recall MitraXs" Self Adjusting Atrial Retractor

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  Class 2 Device Recall MitraXs" Self Adjusting Atrial Retractor see related information
Date Initiated by Firm January 26, 2011
Date Posted February 17, 2011
Recall Status1 Terminated 3 on May 31, 2012
Recall Number Z-1370-2011
Recall Event ID 57850
Product Classification Instruments, surgical, cardiovascular - Product Code DWS
Product MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium.

Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.
Code Information Model - Batch #:  A0030/1 - 32730001; 32765005; 33253005; 347830070  A0031/1 - 32730003; 32765007; 347830080; 33253006  A0032/1 - 32730002; 32765006; 34783090; 32985001  A0033/1 - 32765008; 33253007; 347830100  
Recalling Firm/
Manufacturer
St. Jude Medical Cardiovascular Division
14901 Deveau Pl
Minnetonka MN 55345-2126
For Additional Information Contact
952-933-4700
Manufacturer Reason
for Recall
St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers of the MitraXs Self Adjusting Atrial Retractor. St. Jude Medical has been distributing this product since their acquisition of CLR in late 2008. They have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. As these burrs may
FDA Determined
Cause 2
Process control
Action The firm, St. Jude Medical, sent an "Urgent Medical Device Recall Notice" dated January 26, 201,1 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue use of the product (MitraXs Self Adjusting Atrial Retractor batches) and remove from inventory. St. Jude began production of a new batch of units that will bear the labeling of St. Jude Medical. Shipment of these units started on January 10, 2011. Note: A St. Jude Medical Sales Representative will contact the customer to facilitate removal and reconciliation of the affected product. If you have any questions or concerns, please contact your St. Jude Medical Sales Representative or 651-490-4470 and/or 612-310-7936.
Quantity in Commerce 450
Distribution Worldwide distribution: USA including states of: NJ, OH, MI, and MN; and countries including: BELGIUM, FRANCE, GERMANY, SWITZERLAND, and UNITED KINGDOM.
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.
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