Invivo Xper Flex Cardio Physiomonitoring System Recall: Intermittent Communication Hazard
Invivo recalls Xper Flex Cardio Physiomonitoring systems with intermittent communication between host and FlexCardio. Affected models include Revision A/B with specific serial numbers. Stop using immediately to prevent potential device malfunction.
Use caution until it’s fixed
Intermittent communication between the host system and the FlexCardio
Contact the company
What happened, in plain English
Invivo is recalling Xper Flex Cardio Physiomonitoring systems that may have intermittent communication issues between the host system and FlexCardio. This could lead to inaccurate readings during heart and vascular disease monitoring, which is serious for medical procedures. Read more at govinfonow.com/recall/73135-invivo-xper-flex-cardio-physiomonitoring-system-recall-intermittent-communication-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/73135-invivo-xper-flex-cardio-physiomonitoring-system-recall-intermittent-communication-hazard · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0263-2018
Cite this page
“Invivo Xper Flex Cardio Physiomonitoring System Recall: Intermittent Communication Hazard.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73135-invivo-xper-flex-cardio-physiomonitoring-system-recall-intermittent-communication-hazard. Based on FDA recall #Z-0263-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0263-2018%22&limit=1).
Why it’s dangerous
The system may experience intermittent communication failures between the host device and the FlexCardio component. This can cause inaccurate readings during critical medical procedures, potentially leading to incorrect treatment decisions.
Who’s affected
Healthcare professionals using the Xper Flex Cardio system for invasive heart and vascular monitoring are most at risk. Patients undergoing these procedures may experience inaccurate results if the device malfunctions.
How to tell if you have this one
Check for the product name 'Xper Flex Cardio Physiomonitoring system' with Revision A or B. Serial numbers include 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335, and 860338.
- Brand
Invivo- Category
Medical device
What to do — step by step
Stop Using Immediately
Discontinue use of the Xper Flex Cardio system if it has the listed serial numbers to prevent potential communication failures.
Where it went and when
Where it was distributed
Distributed in 47 states and D.C. and Puerto Rico, and outside the U.S.
FDA distribution: “AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Puerto Rico Algeria, Argentina, Australia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 7.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0263-2018 (August 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0263-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.