Medtronic Recalls DBS Lead Kits Due to Potential Insulation Damage
Medtronic is voluntarily recalling 70 unused DBS lead kits from three lots due to potential insulation damage identified during manufacturing.
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 is classified as FDA Class II, which indicates a potential for temporary or medically reversible adverse health consequences. The hazard is a manufacturing defect (insulation damage) in a medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Neuromodulation is voluntarily retrieving unused Model 3387S-40 and 3389S-40 Deep Brain Stimulation (DBS) lead kits. The recall affects 70 units from three specific manufacturing lot numbers: VA15GPJ, VA15K3N, and VA15K7K. These products were distributed to facilities in Arkansas, California, Florida, Illinois, Maryland, Missouri, Nebraska, New York, Ohio, Tennessee, and Wisconsin.
The recall was initiated because Medtronic identified the potential for lead insulation damage during the manufacturing process of a DBS lead component. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should check their inventory for the affected model numbers and lot codes. If the products are found, they should be removed from use and returned to Medtronic according to the company's instructions.
The recalled product
- Product
- Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- Affected units
- 70
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 (3)
- lots: VA15GPJ
- VA15K3N
- VA15K7K
Distribution
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