FDA Device recall Z-1836-2013
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 inclu…
- FDA Device
- Class II
- terminated
- Published 2013-08-07
On 2013-08-07 the FDA classified a Class II recall of 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 inclu… by St Jude Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1836-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-26 |
| Published | 2013-08-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
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.
Reason
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
Identifiers
| code_info | Multiple lots recalled are the ones with supplier's inner battery lots of 326-508 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1836-2013%22
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