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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68700

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

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Event summary

Timeline bucket
June 19, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boston Scientific CRM Corp

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 ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.

Z-2147-2014
Recall number
Z-2147-2014
Initiated
June 19, 2014
Classification
Class II
Status
Terminated
Quantity
21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.

Code information

Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.

Distribution pattern

Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France