Medtronic Recalls Deep Brain Stimulation Extension Kits Due to Impedance Reports
Medtronic is recalling DBS Extension Kits (Models 37085 and 37086) after receiving reports of high impedances during implant procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk medical device (implantable neurostimulator component) where a functional defect (high impedance) has been reported, but the source text does not explicitly state that injuries or illnesses have occurred, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Neuromodulation is recalling 86,851 units of the Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. The recall is being conducted worldwide, with 37,933 units distributed in the United States and 48,918 units distributed outside the United States. The affected products are sterile and are used with specific implantable Neurostimulators, including the Activa PC (Model 37601), Activa RC (Model 37612), and Activa SC (Model 37603).
The recall was initiated after Medtronic received reports of high impedances during the implant procedure. The company is providing important information regarding the handling of the extensions during these procedures to address the issue. All serial numbers for the specified models are affected.
Patients and healthcare providers who have used or are considering using these specific extension kits should contact Medtronic Neuromodulation for further instructions and information on proper handling during implantation.
The recalled product
- Product
- Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Neurostimulator
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
Distribution
Distribution scope not specified by the agency.
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