FDA Device recall Z-0263-2018
Xper Flex Cardio Physiomonitoring system
- FDA Device
- Class II
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class II recall of Xper Flex Cardio Physiomonitoring system by Invivo, citing intermittent communication between the host system and the FlexCardio.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0263-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-18 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Invivo |
| Distribution | AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
Product
Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
Reason
Intermittent communication between the host system and the FlexCardio
Identifiers
| code_info | All Flex Cardio devices, Revision A, B Code Number's: 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335 and 860338 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0263-2018%22
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