Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Depth Stop Defect
Medtronic is recalling Deep Brain Stimulation lead kits because the depth stop may not secure properly, potentially causing the lead to be placed beyond the intended target.
What this means for you
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. The hazard involves a medical device defect that can lead to incorrect lead placement, which is a risk of harm, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Neuromodulation is recalling specific Deep Brain Stimulation (DBS) lead kits, including models 3387/3387S, 3389/3389S, and 3391/3391S. The recall involves the DBS Lead Depth Stop, an accessory used during implant procedures to mark distance and control lead depth.
The recall was initiated after Medtronic received reports that the DBS depth stop did not adequately secure to the lead. This defect can result in the DBS lead being placed beyond the intended target during the implant procedure.
The affected products were distributed worldwide, including in the United States and numerous foreign countries. The source text does not specify the number of affected units, specific lot numbers, or reported injuries. Consumers and healthcare providers should contact Medtronic for further instructions on how to proceed with the recall.
The recalled product
- Product
- DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead h
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 86,024
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 (20)
- Model 3387
- Lot Serial #: 0206880294
- 0206882647
- 0206882779
- 0206882780
- 0206882781
- 0206882782
- 0206882783
- 0206886184
- 0206886323
- 0206886328
- 0206886330
- 0206886331
- 0206886332
- 0206886333
- 0206886603
- 0206887813
- 0206890443
- 0206890444
- 0206903488
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