Exact FDA event identifier

Event 64538

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

Open FDA event record

Event summary

Timeline bucket: February 14, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Elana, Inc.

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

Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.

Z-1143-2013

Recall number: Z-1143-2013
Initiated: February 14, 2013
Classification: Class II
Status: Terminated
Recalling firm: Elana, Inc.
Quantity: 3 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Distribution of an unapproved device into interstate commerce.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Distribution of an unapproved device into interstate commerce.

Code information

Model 280, S/N 776, S/N 706, S/N 758

Distribution pattern

Distributed in the states of Pennsylvania, Texas, and New York.