Class 2 Device Recall Medtronic HMS PLUS, Hemostasis Management System with Heparin Assay Controls

• Date Initiated by Firm: March 08, 2010
• Date Posted: May 04, 2010
• Recall Status: Terminated on December 31, 2011
• Recall Number: Z-1537-2010
• Recall Event ID: 55169
• Product Classification: System, multipurpose for in vitro coagulation studies - Product Code JPA
• Product: Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.
• Code Information: HMS Plus Catalog Number: 30514; Heparin Assay Controls: 306-01POR, 306-02POR, 306-03POR, 306-04POR, 306-05POR and 306-09POR.
• Recalling Firm/ Manufacturer: Medtronic Inc. Cardiac Rhythm Disease Managment; 8200 Coral Sea St. N.E.; Saint Paul MN 55112
• For Additional Information Contact: 763-514-4000
• Manufacturer Reason for Recall: The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.
• FDA Determined Cause: Process change control
• Action: Medtronic issued an "Urgent Medical Device Notification" letter dated March 8, 2010 addressed to "Dear Valued Customer" and was sent to three locations at each customer site: Risk Management, Cardiovascular Surgery and Clinical Laboratory-Point of Care. The letter described the product and the issue, provided instructions for control and patient testing. The customer was requested to return an enclosed certificate as proof of notification. For further information, contact your Medtronic Sales Representative or call 1-763-391-9915.
• Quantity in Commerce: 508 US, 36 OUS
• Distribution: Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and 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.