The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1738-2013·Announced 2013-07-24

St. Jude Medical Recalls Eon Spinal Cord Stimulator Charging Systems

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 significant injuries, specifically second-degree and first-degree burns, which aligns with the 'Severe' criteria for significant injury reports.

Plain-English summary

St. Jude Medical is recalling the Eon and Eon Mini charging systems, specifically the 3701 Wall Charger and 3711 Portable Charger. These devices are used to charge spinal cord stimulators indicated for the management of chronic intractable pain of the trunk and/or limbs. The recall covers 70,638 units distributed worldwide, including the United States, Puerto Rico, and various international markets.

The recall was initiated after reports of discomfort associated with heating at the device site while patients were using the charging systems. In three specific cases, patients received skin burns at the implant site, including one second-degree burn and two first-degree burns. The source text does not specify the total number of discomfort reports beyond the three burn cases.

Patients using these devices should contact their doctor or St. Jude Medical for instructions on how to proceed. The recall includes all serial numbers manufactured for these specific charger models.

The recalled product

Product
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon 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…
Manufacturer
St. Jude Medical
Category
Medical Device — Spinal Cord Stimulator Accessories
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 →

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