FDA Device recall Z-2106-2013
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin)
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin) by Medtronic Cardiac Rhythm Disease Management, citing 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 Pac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2106-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-17 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot: 11646955, 11669565, 11672312, 11713195, 11724203, 11749965, 11750036, 11787651, 11799982, 11822299, 11822308, 118…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2106-2013%22
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