ClearSight — Class II medical device recall Z-1732-2015
Terminated recall by Edwards Lifesciences, LLC, reported 2015-06-17, distributed nationwide. Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sen
| Recall number | Z-1732-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2015-05-18 |
| Classified | 2015-06-09 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2015-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, CH, CZ, DK, EE, ES, FI, FR, GB, GR, HU, IE, IT, KW, NL, OM, PL, PT, QA, RO, SA, SE, SI, SK, TR, ZA |
Product
ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Reason for recall
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
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-1732-2015. 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.