The Recall Desk
SevereFDA (Devices)·Z-1739-2013·Announced 2013-07-24

St. Jude Medical Recalls Eon Mini Spinal Cord Stimulator Chargers

St. Jude Medical is recalling Eon Mini chargers due to reports of skin burns and discomfort at the implant site during charging.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reported injuries, specifically skin burns (one second-degree and two first-degree), which meets the criteria for a Severe rating.

Plain-English summary

St. Jude Medical is recalling the Eon Mini - 3721 Charger, a component of the Eon Mini spinal cord stimulator system. The recall involves 70,638 combined units of Eon and Eon Mini systems distributed worldwide, including the United States and numerous international markets.

The recall was initiated after reports of discomfort associated with heating at the device site while patients used the Charging System. In three specific cases, patients sustained skin burns at the implant site, including one second-degree burn and two first-degree burns.

Patients using the Eon Mini system should contact their doctor or St. Jude Medical for further instructions regarding the use of the charging system.

The recalled product

Product
Eon Mini - 3721 (Charger). Product Usage: 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
Manufacturer
St. Jude Medical
Category
Medical Device — Spinal Cord Stimulator
Hazard
Affected units
70,638

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers manufactured

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by St. Jude Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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Same hazard · burn injury

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