Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO
Medical device recall Z-1365-2015. Published in FDA’s Enforcement Report on Apr 8, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 8, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 8,269 ( 6,786 US, 1,483 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
8,269 ( 6,786 US, 1,483 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Lot Number” BVT608010 551902 BVT608010 551975 BVT608010 552014 BVT608030 551796 BVT608030 551873 BVT608030 551893 BVT608030 551923 BVT608030 552011 BVT608030 552097 BVT612010 551789 BVT612010 551837 BVT612010 551894 BVT612010 551974…
Every code shown here, 2,000 characters
Model Lot Number” BVT608010 551902 BVT608010 551975 BVT608010 552014 BVT608030 551796 BVT608030 551873 BVT608030 551893 BVT608030 551923 BVT608030 552011 BVT608030 552097 BVT612010 551789 BVT612010 551837 BVT612010 551894 BVT612010 551974 BVT612010 551976 BVT612010 552030 BVT612010 552226 BVT612030 551808 BVT612030 551903 BVT612030 551904 BVT612030 551924 BVT612030 551980 BVT612030 552007 BVT612030 552017 BVT612030 552034 BVT612030 552071 BVT612030 552081 BVT612030 552229 BVT808015 551466 BVT808015 551797 BVT808015 551804 BVT808015 551895 BVT808015 551942 BVT808015 551950 BVT808015 551984 BVT808015 552020 BVT808015 552027 BVT808015 552067 BVT808015 552113 BVT808030 551436 BVT808030 551437 BVT808030 551464 BVT808030 551798 BVT808030 551803 BVT808030 551812 BVT808030 551841 BVT808030 551863 BVT808030 551897 BVT808030 551899 BVT808030 551922 BVT808030 551943 BVT808030 551947 BVT808030 551977 BVT808030 551981 BVT808030 551986 BVT808030 551999 BVT808030 552010 BVT808030 552012 BVT808030 552028 BVT808030 552084 BVT808030 552100 BVT808030 552119 BVT808030 552120 BVT808030 552146 BVT808030 552168 BVT808030 552174 BVT808030 552180 BVT812015 551471 BVT812015 551805 BVT812015 551816 BVT812015 551891 BVT812015 551944 BVT812015 551978 BVT812015 552021 BVT812015 552099 BVT812015 552181 BVT812030 551465 BVT812030 551472 BVT812030 551474 BVT812030 551802 BVT812030 551815 BVT812030 551844 BVT812030 551864 BVT812030 551890 BVT812030 551905 BVT812030 551948 BVT812030 551970 BVT812030 551982 BVT812030 551993 BVT812030 552018 BVT812030 552035 BVT812030 552073 BVT812030 552117 BVT812030 552145 BVT812030 552149 BVT812030 552169 EUT808015 551889 EUT808015 551949 EUT808015 552023 EUT808015 552085 EUT808015 552144 EUT808030 551826 EUT808030 551865 EUT808030 552008 EUT808030 552013 EUT808030 552069 EUT808030 552096 EUT808030 552123 EUT808030 552147 EUT812015 551898 EUT812015 552001 EUT812015 552177 EUT812030 551829 EUT812030 551866 EUT812030 551994 EUT812030 552019 EUT812030 552086 EUT812030…
FDA’s list runs to 14,407 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (nationwide) including all states in continental USA, except DE and including DC and PR; and countries: AUSTRIA, AUSTRALIA, NEW ZEALAND, BELGIUM, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, IRELAND, ITALY, NETHERLANDS, POLAND, PORTUGAL, ROMANIA, RUSSIA, SPAIN, SWEDEN SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, EL SALVADOR, PANAMA, and CANADA.
The states and territories these words name
- District of Columbia
- Puerto Rico
They leave out Delaware.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 23, 2015.
- FDA classified it on Apr 1, 2015.
- FDA’s Enforcement Report published it on Apr 8, 2015.
- FDA terminated it on Aug 11, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc. Cardiac Rhythm Disease Management, of Saint Paul, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 14,407 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.