Covidien Trellis-8 Peripheral Infusion System — Class I medical device recall Z-1018-2015
Terminated recall by Covidien, reported 2015-02-11, distributed nationwide. A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identificat
| Recall number | Z-1018-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, Plymouth, MN, United States |
| Recall initiated | 2014-12-10 |
| Classified | 2015-02-02 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2016-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, ES, FI, FR, GB, IE, IT, SE, TR |
| Reason classes | labeling |
| Lot numbers | 9895996, 9904237, 9904401, 9904675, 9904676, 9906429, 9910270, 9910342, 9910934, 9911492, 9911683, 9911812, 9911926, 9912003, 9912084, 9912117, 9912200, 9912261, 9912387, 9912503, 9922490, 9922498, 9922584, 9922597, 9922601, 9922604, 9922606, 9922617, 9922620, 9922624, 9922635, 9922644, 9922658, 9922661, 9922663, 9922739, 9922742, 9922750, 9922753, 9922793 and 173 more |
| Model numbers | CVT808015, CVT808025, CVT812015, CVT812025 |
Product
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Reason for recall
A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal.
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-1018-2015. 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.