Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems — Class II medical device recall Z-1365-2015
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2015-04-08, distributed nationwide. Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion
| Recall number | Z-1365-2015 |
|---|---|
| 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 | 2015-03-23 |
| Classified | 2015-04-01 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2016-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CZ, DE, DK, EG, ES, FI, FR, GB, IE, IT, NL, NZ, PA, PL, PT, RO, RU, SE, SV, TR |
| Reason classes | sterility |
| Lot numbers | 551436, 551437, 551464, 551465, 551466, 551471, 551472, 551474, 551789, 551796, 551797, 551798, 551802, 551803, 551804, 551805, 551808, 551812, 551815, 551816, 551826, 551829, 551837, 551841, 551844, 551863, 551864, 551865, 551866, 551873, 551889, 551890, 551891, 551893, 551894, 551895, 551897, 551898, 551899, 551902 and 460 more |
| Model numbers | 551436, 551437, 551464, 551465, 551466, 551471, 551472, 551474, 551789, 551796, 551797, 551798, 551802, 551803, 551804, 551805, 551808, 551812, 551815, 551816, 551826, 551829, 551837, 551841, 551844 and 475 more |
Product
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Reason for recall
Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch.
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-1365-2015. 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.