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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Custom Perfusion System

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  Class 2 Device Recall Medtronic Custom Perfusion System see related information
Date Initiated by Firm July 17, 2013
Date Posting Updated August 27, 2013
Recall Status1 Terminated 3 on February 04, 2014
Recall Number Z-2105-2013
Recall Event ID 65831
510(K)Number K891687  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7.
Sterilized by Ethylene Oxide, Do no Reuse.

Product Usage: Usage:
This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
Code Information Lot: 12096267, 12105099, 12139669, 12166396, 12198322, 12309957, 12416020, 206119223, 206120062, 206180336, 206233199, 206384131, 206496179, 206649807, 206699258, 206758209, 206851971, 206864385, 206919887, 207003072, and 207071455.
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul MN 55112-4391
For Additional Information Contact
Manufacturer Reason
for Recall
Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
FDA Determined
Cause 2
Process control
Action Metronic sent an "Urgent Field Safety Notice" letter dated July, 2013 to all affected customers. The letter described the affected product, problem and actions to be taken by User. Customerss were advised to remove and destroy all affected products. At the same time customers were informed that replacement products can be ordered by contacting their Medtronic representative. Customers were requested to complete the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612. For any questions they can contact Medtronic Lifeline Technical Services at 877-526-7890 or their Medtronic representative.
Quantity in Commerce 217
Distribution Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
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 = DTZ and Original Applicant = MEDTRONIC BLOOD SYSTEMS, INC.