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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63108

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

Open FDA event record

Event summary

Timeline bucket
July 26, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
St. Jude Medical

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

Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.

Z-1836-2013
Recall number
Z-1836-2013
Initiated
July 26, 2012
Classification
Class II
Status
Terminated
Recalling firm
St. Jude Medical
Quantity
34,617

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanne

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanne

Code information

Multiple lots recalled are the ones with supplier's inner battery lots of 326-508

Distribution pattern

Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.