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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71246

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 18, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Edwards Lifesciences, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Z-1732-2015
Recall number
Z-1732-2015
Initiated
May 18, 2015
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
1,309 units total (696 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.

Code information

All serial numbers. From 600104000221 to 600104005025

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Estonia, Italy, Romania, Sweden, Austria, Finland, Kuwait, Saudi Arabia, Switzerland, Bahrain, France, Netherlands, Slovenia, Turkey, Belgium, Great Britain, Oman, Slovakia, South Africa, Bulgaria, Greece, Poland, South Africa, United Arab Emirates, Czech Republic, Hungary, Portugal, Spain, Denmark, Ireland, and Qatar.