Medtronic Recalls DBS Pocket Adaptors Due to Conductor Wire Fracture Risk
Medtronic is recalling DBS Pocket Adaptors Models 64001 and 64002 due to potential conductor wire fractures. A safety notification was sent to healthcare professionals regarding device handling and integrity checks.
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 involves a risk-of-harm product (conductor wire fracture in an implanted medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Neuromodulation is recalling the DBS Pocket Adaptor, Model 64001 and Model 64002. These devices are used as part of a neurostimulation system for deep brain stimulation and are intended to be implanted with a new replacement neurostimulator in the same pocket used for the explanted neurostimulator.
The recall is due to the potential for pocket adaptor conductor wire fractures. A safety notification was sent to healthcare professionals to reinforce device-specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.
The recall affects 7,542 units in the US and 12,999 units outside the US, with worldwide distribution. The notification is not lot specific. Healthcare professionals should refer to the safety notification for specific guidance on handling and integrity checks.
The recalled product
- Product
- DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimula
- Manufacturer
- Medtronic Neuromodulation
- Hazard
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)
- Notification is not lot specific.
Distribution
Distribution scope not specified by the agency.
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