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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-2119-2020 - ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Ster... 2 05/26/2020 Boston Scientific Neuromodulation Corporation
Z-2120-2020 - Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration... 2 05/26/2020 Boston Scientific Neuromodulation Corporation
Z-2121-2020 - LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to t... 2 05/26/2020 Boston Scientific Neuromodulation Corporation
Z-2125-2020 - Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus... 2 05/26/2020 Boston Scientific Neuromodulation Corporation
Z-2123-2020 - Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of ch... 2 05/26/2020 Boston Scientific Neuromodulation Corporation
Z-2124-2020 - Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spi... 2 05/26/2020 Boston Scientific Neuromodulation Corporation
Z-2122-2020 - The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of t... 2 05/26/2020 Boston Scientific Neuromodulation Corporation
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