CLASS II Device recall · Reported 15 Nov 2017 · FDA Enforcement Report
Xper Flex Cardio PhysioMonitoring system The Xper Flex recalled
Invivo is recalling Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is, distributed in 30 states. The recall was initiated on 11 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0082-2018
- FDA event ID
- 78465
- Recalling firm
- Invivo, Orlando, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Aug 2017
- FDA classified
- 9 Nov 2017
- Reported
- 15 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Heart & Vascular Devices
Timeline
| 11 Aug 2017 | Recall initiated by company | |
| 9 Nov 2017 | Classified by FDA | +90 days |
| 15 Nov 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Intermittent communication between the host system and the Flex Cardio
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
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, South Africa and Tunisia.
AlaskaAlabamaArizonaCaliforniaColoradoDelawareFloridaGeorgiaIowaIdahoIllinoisKentuckyLouisianaMassachusettsMichiganMissouriNorth CarolinaNebraskaNew MexicoNew York
Questions about this recall
Why was it recalled?
Intermittent communication between the host system and the Flex Cardio
Which lots are affected?
Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C
Where was it sold?
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, South Africa and Tunisia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Invivo
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | MR Coils The MR Coil is intended to be used recalled by Invivo | Invivo | Other | Nationwide |
| Device | CLASS II | Monitor for the Functional Imaging System recalled by Invivo | Invivo | Other | 17 states |
| Device | CLASS II | Xper Flex Cardio Physiomonitoring System recalled by Invivo | Invivo | Device Malfunction | FL |
| Device | CLASS II | Xper Flex Cardio Physiomonitoring System recalled by Invivo | Invivo | Labeling Errors | FL |
| Device | CLASS II | Xper Flex Cardio Physiomonitoring System The Xper Flex recalled | Invivo | Temperature Abuse | Nationwide |
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| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |