FDA Devices recall · Reported February 11, 2015
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.
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 ball…
Covidien recalled Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612… - a critical-severity action.
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612… was recalled by Covidien in February 11, 2015. Reason: A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identifica…. Check the official notice for the remedy. Verify recall #Z-1017-2015 with the FDA Devices before acting.
The recall
Covidien issued this critical-severity FDA Devices recall-A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identifica….
- Critical
- severity level
- 216 units
- affected scope
- Class I
- classification
- February 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1017-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1017-2015) was formally reported on February 11, 2015, with the manufacturer initiating the action on December 10, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Covidien is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 216 devices (207 US, 9 OUS).
The documented reason for this recall is: 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 a… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1017-2015 |
| Date reported | February 11, 2015 |
| Date initiated | December 10, 2014 |
| Recalling firm | Covidien |
| Firm location | Plymouth, MN |
| Affected scope | 216 devices (207 US, 9 OUS) |
| Distribution | Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1017-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026