Invivo Xper Flex Cardio PhysioMonitoring System Recall: Intermittent Communication Hazard
Invivo recalls Xper Flex Cardio devices with intermittent communication between host system and Flex Cardio. This may cause inaccurate readings during heart and vascular monitoring. Affected models include 453564621791 and :453564621801 (Revision C).
Use caution until it’s fixed
Intermittent communication between the host system and the Flex Cardio
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 the Flex Cardio device. This could lead to inaccurate readings during heart and vascular monitoring, potentially affecting patient safety. Read more at govinfonow.com/recall/73146-invivo-xper-flex-cardio-physiomonitoring-system-recall-intermittent-communication-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/73146-invivo-xper-flex-cardio-physiomonitoring-system-recall-intermittent-communication-hazard · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0082-2018
Cite this page
“Invivo Xper Flex Cardio PhysioMonitoring System Recall: Intermittent Communication Hazard.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73146-invivo-xper-flex-cardio-physiomonitoring-system-recall-intermittent-communication-hazard. Based on FDA recall #Z-0082-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0082-2018%22&limit=1).
Why it’s dangerous
The system may experience intermittent communication failures between the host system and the Flex Cardio device. This can cause inaccurate readings for critical heart and vascular monitoring data, which could impact patient safety if not addressed.
Who’s affected
Healthcare providers using the Xper Flex Cardio system for heart and vascular monitoring are most at risk. The system is used by physicians, nurses, and clinical technicians to analyze patient data.
How to tell if you have this one
Check for model numbers 453564621791 or 453564621801 on the device. The recall applies to all Flex Cardio devices with Revision C.
- Brand
Invivo- Category
Medical device
What to do — step by step
Check Device Model
Look for model numbers 453564621791 or 453564621801 on the device.
Where it went and when
Where it was distributed
Distributed in 30 states, and outside the U.S.
FDA distribution: “Worldwide Distribution - US including AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OR, OK, PA, SD, TN, TX, VA, WA, WV and Internationally to Germany, Hungary, India, Netherlands, Russia, Saudi Arabia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia.
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.
Similar recalls
Latest medical device recalls
Keep exploring
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-0082-2018 (August 11, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0082-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.