Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01 Recalled by Covidien Due to A manufacturing error resulted in the risk of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien directly.
Affected Products
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Quantity: 216 devices (207 US, 9 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien
Covidien has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report