Medtronic Custom Perfusion System with Trillium BioSurface — Class II medical device recall Z-2106-2013
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2013-09-04, distributed nationwide. Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, mo
| Recall number | Z-2106-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2013-07-17 |
| Classified | 2013-08-27 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 758 |
| Lot numbers | 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 and 15 more |
| Model numbers | TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, TL6A65R7 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2106-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.