Medtronic Recalls DBS Therapy Kits Due to Potential Lead Damage
Medtronic is recalling DBS Therapy for Dystonia Kits because the provided lead cap may damage the lead connector, potentially compromising the device.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end…"
Plain-English summary
Medtronic Neuromodulation is recalling Medtronic DBS Therapy for Dystonia Kits, models 3317, 3339, 3337, and 3339. The recall involves 30,000 units that were distributed worldwide, including in the United States and numerous international markets.
The recall is due to a potential for lead damage. Medtronic has received reports that the DBS leads were damaged at the connector end when the lead cap provided in the kits was used. The connector end is the part of the lead that connects to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and damage the lead.
Medtronic is providing additional instructions for capping the lead and removing the lead cap. The lead kits are not being removed from the market, but users should follow the new instructions to prevent damage.
The recalled product
- Product
- Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in…
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 30,000
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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