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Recall Observatory FDA recall evidence

Device product

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.

Z-2106-2013

July 17, 2013

Class II

Product summary

Firm
Medtronic Inc. Cardiac Rhythm Disease Management
Event
Event 65831
Status
Terminated
Classification
Class II
Quantity
758
Official record key
device-enforcement:Z-2106-2013

Official wording

Reason: 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.

Code information: Lot: 11646955, 11669565, 11672312, 11713195, 11724203, 11749965, 11750036, 11787651, 11799982, 11822299, 11822308, 11878727, 11892549, 11908754, 11977672, 11982378, 11990416, 12019895, 12033691, 12075354, 12089790, 12096228, 12105079, 12111165, 12139696, 12155284, 12172596, 12178118, 12182890, 12191658, 12204951, 12204958, 12221793, 12227544, 12233759, 12236465, 12292171, 12323842, 12385431, 12399363, 12403798, 206110970, 206141990, 206142625, 206388507, 206476850, 206618547, 206649829, 206720637, 206758173, 206758215, 206851679, 206919848, 207003064, and 207030516.

Distribution pattern: Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.