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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67658

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

Open FDA event record

Event summary

Timeline bucket
March 03, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boston Scientific 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

Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.

Z-1164-2014
Recall number
Z-1164-2014
Initiated
March 03, 2014
Classification
Class II
Status
Terminated
Quantity
7

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
pouch of the devices from this lot may not be completely sealed and sterility may be compromised
Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.

Code information

2013040058

Distribution pattern

TX and Russia

Field note

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