Reported Feb 14, 2018 · Terminated

VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for…

Cyberonics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cyberonics, Inc · 100 Cyberonics Blvd · Houston, TX · 77058-2069

VNS(R) Therapy Programmer
GMDN
- 44077
- Model 3000 v1.0.2.2
Intended Use/IndicationsUnited
States Indications for UseEpilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications
DepressionVNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments

Lot codes and dates: Part Number10-0011-0500
Serial number/UDI8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500
Amount recalled: 2 units

Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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