Reported Dec 27, 2017 · Terminated

Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when…

Invivo Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Invivo Corporation · 12151 Research Pkwy Ste 200 · Orlando, FL · 32826-3286

Is this the product you have?

  • Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
Lot codes and dates
  • All Flex Cardio devices, Revision A
  • B Code Number's
    • 453564241901
    • 453564241911
    • 453564483321
    • 453564483331
    • 989803185601
    • 9898031930191
    • 860335 and 860338
Amount recalled
4,535

Where it was sold

Why it was recalled

Intermittent communication between the host system and the FlexCardio

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 20, 2024 · Data as of Sep 19, 6:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.