Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring Recalled by Invivo Corporation Due to Intermittent communication between the host system and the...

Date: August 11, 2017
Company: Invivo Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Invivo Corporation directly.

Affected Products

Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.

Quantity: 529

Why Was This Recalled?

Intermittent communication between the host system and the Flex Cardio

Where Was This Sold?

This product was distributed to 30 states: AL, AK, AZ, CA, CO, DE, FL, GA, ID, IL, IA, KY, LA, MA, MI, MO, NE, NM, NY, NC, OH, OK, OR, PA, SD, TN, TX, VA, WA, WV

Affected (30 states)Not affected

About Invivo Corporation

Invivo Corporation has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report