Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio… — Class II medical device recall Z-0082-2018
Terminated recall by Invivo Corporation, reported 2017-11-15, distributed in AK, AL, AZ, CA, CO, DE, FL, GA…. Intermittent communication between the host system and the Flex Cardio
| Recall number | Z-0082-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Orlando, FL, United States |
| Recall initiated | 2017-08-11 |
| Classified | 2017-11-09 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2024-09-20 |
| Distributed | AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WV |
| Countries outside the US | DE, HU, IN, NL, RU, SA, TN, ZA |
| Quantity | 529 |
| Model numbers | 453564621791, 453564621801 |
Product
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.
Reason for recall
Intermittent communication between the host system and the Flex Cardio
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.