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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64273

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

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Event summary

Timeline bucket
February 05, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cordis Corporation

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

Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.

Z-1784-2014
Recall number
Z-1784-2014
Initiated
February 05, 2013
Classification
Class II
Status
Terminated
Recalling firm
Cordis Corporation
Quantity
80 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

Code information

Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08

Distribution pattern

Worldwide distribution: US states: AZ, FL, IL, LA, MA, NJ, OR, SC, and TX. Armenia, Austria, Belgium, Colombia, Czech Republic, France, Hungary, Iran, Israel, India, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Switzerland, and United Arab Emirates.