Xper Flex Cardio Physiomonitoring system — Class II medical device recall Z-0263-2018
Terminated recall by Invivo Corporation, reported 2017-12-27, distributed in AK, AL, AZ, CA, CO, CT, DC, DE…. Intermittent communication between the host system and the FlexCardio
| Recall number | Z-0263-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Orlando, FL, United States |
| Recall initiated | 2017-08-18 |
| Classified | 2017-12-19 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2024-09-20 |
| Distributed | 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 |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BO, CA, CH, CL, CN, CO, CY, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, HN, HU, ID, IE, IL, IN, IR, IS, IT, JO, KE, KR, KY, LB, LK, LT, MA, MX, MY, NL, NO, NP, NZ, OM, PA, PH, PK, PL, PY, QA, RO, SA, SE, SG, TH, TN, TR, TW, UA, VN, ZA |
| Quantity | 4,535 |
Product
Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
Reason for recall
Intermittent communication between the host system and the FlexCardio
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0263-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.