Vigilance II Monitor Model: VIG2/VIG2E Software: versions… recallZ-0942-2012 · Edwards Lifesciences, Llc · initiated Sep 12, 2008
Terminated All recalls posted in February 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Edwards Lifesciences, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of inaccurate Injectate Cardiac Output (ICO) measurements.
FDA root cause category: Device Design
What the company is doing
Edwards initiated two Urgent Product Notification - Action Required letters to all affected customers. The letters identified the affected product, problem, and actions to be taken. The letters instructed users to immediately discontinue use of in-line temperature probes for Intermittent Cardiac Output (ICO) measurements on the Vigilance II instrument and recommends use of the bath probe only (model 9850A) to measure the temperature of the injectate solution for ICO calculations, until software update have been completed. Customers were instructed to complete and return a software upgrade form to Edwards as record of completion. For questions call Edwards Technical Support department at 800-822-9837.
Recall details
- Recall number
- Z-0942-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 12, 2008
- Posted by the FDA
- Feb 2, 2012
- Recalling firm
- Edwards Lifesciences, Llc
- Quantity
- 6934 instruments
- Product code
- DXG
- FDA submissions
- K043103
- Distribution
- Worldwide Distribution - Nationwide Distribution (USA) - and the countries of: Argentina, Australia/ New Zealand, Brazil, Canada, China, Columbia, Ecuador, Europe, Indonesia, Japan, Korea, Macao, Malaysia, Mexico, Middle East, Peru, Puerto Rico, Singapore, Thailand, Taiwan and Venezuela
Product description
Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.
Code information (models, lots, serial numbers)
Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Serial numbers: VG000031 to VG007468
Other devices under the same FDA submission
1 device cleared under K043103 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SWAN-GANZ 70CC2Edwards Lifesciences LLC · COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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