Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the
FDA device recall Z-1599-2010 · posted 2010-05-13 · Terminated
Recall details
- Recalling firm
- Advanced Neuromodulation Systems, Inc
- Reason for recall
- Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.
- Action taken
- St. Jude Medical issued an "Important Medical Device Information" notification dated April 2010. Consignees were informed of the affected product and instructed on necessary steps. Any returned product should be sent to the firm. For further information, contact your St. Jude Medical Neuromodulation Division Sales Representative or call 1-972-309-2154.
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- LGW
- Quantity affected
- 7 devices
- Distribution
- Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.
- Date initiated
- 2010-04-23
- Date posted
- 2010-05-13
- Date terminated
- 2015-07-27
- Location
- Plano, TX
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