Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
FDA Recall Z-2106-2013 · Posted 2013-08-27
Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
Recall StatusTerminated
Product CodeDWF
Date Initiated2013-07-17
Date Terminated2014-02-04
Product Quantity758
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.