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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93791

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

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Event summary

Timeline bucket
January 05, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
IMPULSE DYNAMICS (USA) 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

OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

Z-1173-2024
Recall number
Z-1173-2024
Initiated
January 05, 2024
Classification
Class II
Status
Ongoing
Quantity
1,469 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.

Code information

OPTIMIZER Smart Mini UDI-DI: 00810003380098 OPTIMIZER Lite UDI-DI: 00810003380142 All units potentially affected. The available software versions that allow the issue to manifest are 1.5.0 and 1.9.1.

Distribution pattern

Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.