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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81006

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

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Event summary

Timeline bucket
September 10, 2018
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

Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

Z-3260-2018
Recall number
Z-3260-2018
Initiated
September 10, 2018
Classification
Class II
Status
Terminated
Quantity
74 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.

Code information

Serial Numbers: 001343 000488 000903 001404 000923 001352 001441 000203 000224 000255 000284 000434 000441 000445 000501 000515 000519 000521 000534 000536 000546 000553 000578 000588 000601 000602 000605 000606 000609 000610 000616 000617 000620 000628 000631 000633 000634 000636 000637 000638 000643 000644 000661 000664 000666 000667 000669 000671 000673 000677 000679 000682 000688 000690 000691 000700 000710 000717 000719 000720 000723 000726 000746 000757 000765 000924 001125 001556 001562 001564 001571 001574 001615 000598

Distribution pattern

Worldwide distribution - US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland