Device recall: Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01.…
Class I FDA enforcement event 70048. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Covidien started this device recall on 10 Dec 2014. The firm address in the FDA record is in Plymouth, MN. FDA put the recall in Class I. FDA event 70048 has 2 product records. The first FDA enforcement report date is 11 Feb 2015. The record gives the status Terminated, with the termination date 31 Mar 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Recalling firm
Covidien, Plymouth, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1017-2015 | 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. | 216 devices (207 US, 9 OUS) | Class I | Terminated | 11 Feb 2015 |
| Z-1018-2015 | 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,… | 1032 devices (919 US, 113 OUS) | Class I | Terminated | 11 Feb 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class I
- 5%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 17
Other events of the firm
Official channels
- FDA enforcement report Z-1017-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 70048. https://recallregister.com/fda/i/70048/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- What quantity of product is in FDA event 70048?
- The event has 2 product records. The first record gives this quantity:
216 devices (207 US, 9 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 5% of the 1,176 device events that started in 2014 are in Class I.