CLASS II Device recall · Reported 27 May 2015 · FDA Enforcement Report
Medtronic DBS Extension Kit for Deep Brain Stimulation recalled
Medtronic Neuromodulation is recalling Medtronic DBS Extension Kit for Deep Brain Stimulation. The recall was initiated on 16 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1617-2015
- FDA event ID
- 71016
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2015
- FDA classified
- 15 May 2015
- Reported
- 27 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Apr 2015 | Recall initiated by company | |
| 15 May 2015 | Classified by FDA | +29 days |
| 27 May 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa¿ PC (Model 37601), Activa¿ RC (Model 37612), and the Activa¿ SC (Model 37603).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Where it was distributed
worldwide
Questions about this recall
Is Medtronic DBS Extension Kit for Deep Brain Stimulation recalled?
Yes. Medtronic Neuromodulation recalled Medtronic DBS Extension Kit for Deep Brain Stimulation on 16 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1617-2015.
Why was it recalled?
Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa¿ PC (Model 37601), Activa¿ RC (Model 37612), and the Activa¿ SC (Model 37603).
Which lots are affected?
all Serial numbers
Where was it sold?
worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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