Reported Dec 26, 2012 · Terminated
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in:…
Medtronic Neuromodulation
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: Medtronic Neuromodulation · 7000 Central Ave NE · Minneapolis, MN · 55432-3568
Is this the product you have?
25 of 25 products
| Model / number | Product as published |
|---|---|
7428 | or Soletra¿ |
7426 | Neurostimulator ¿ Activa¿ PC |
37601 | Activa RC |
37612 | Activa SC |
37602 | or Activa SC |
37603 | Neurostimulator ¿ |
7482 | — |
7482A | — |
7483 | — |
37085 | or |
37086 | Extension ¿ |
3387 | or |
3389 | Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ¿ Soletra |
7426 | Neurostimulator ¿ Activa PC |
37601 | Activa RC |
37612 | Activa SC |
37602 | or Activa SC |
37603 | Neurostimulator ¿ |
7482 | — |
7482A | — |
- Lot codes and dates
NHU236350V to NHU236373VNKN037257V to NKN037259VNKN037372V to NKN037387VNKN037476V to NKN037507VNKN037692V to NKN037698VNKN037772V to NKN037779VNKN037790V to NKN037810VNKN037812V to NKN037840V
- Amount recalled
- 140 units
Where it was sold
Why it was recalled
Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot.
This product could cause temporary or reversible health problems — stop using it.
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