St. Jude Medical Recalls Eon and Eon Mini Charging Systems
St. Jude Medical is recalling Eon and Eon Mini charging systems due to reported warmth or heating at the implant site during charging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (heating at the implant site) where the source text does not explicitly report injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
St. Jude Medical is recalling the Eon and Eon Mini charging systems, including model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger), and Eon Mini -3721 (Charger). This recall is a continuation of the firm's July 2012 recall and involves 75,663 units distributed worldwide, including the United States and numerous international countries.
The recall is being conducted because of issues involving warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). The source text indicates that the firm previously informed customers of design improvements to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface.
The affected products are used to recharge IPG batteries by transmitting RF energy through an antenna. The Eon Wall Charger and Portable Charger allow for recharging, with the portable version allowing patient mobility. The Eon Mini Charger allows recharging while stimulation is either on or off. Consumers and healthcare providers should refer to the recalling firm for specific instructions on handling these devices.
The recalled product
- Product
- Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG Batte
- Manufacturer
- St. Jude Medical
- Hazard
- Affected units
- 75,663
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
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