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Boston Scientific Neuromodulation

United States·US-MF-000004703

Last updated September 17, 2026

Information

Country: United States
Address: 25155, Rye Canyon Loop, Valencia, United States
Website: www.bsci.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 651-582-5934
PRRC Contact: Karou Lee Adair
EUDAMED SRN: US-MF-000004703
FDA FEI Number: 3006630150
DUNS Number: —

Catalogue (349)

Page 1 of 7

Device	Model / Reference	Registries	Class	Status
SideKick™ 2	RFK-C101020S-ZK2	FDA UDI	Class II	Active
Vercise™	DB-9208-55	FDA UDI	Class III	Active
Superion™	101-9812	FDA UDI	Class III	Active
Linear ™	SC-2352-50E	FDA UDI	Class III	Active
Spectra WaveWriter™	SC-1160	FDA UDI	Class III	Active
Entrada ™	SC-4220-S45	FDA UDI	Class III	Active
CoverEdge™ X 32	SC-8352-70	FDA UDI	Class III	Active
Linear ™	SC-2158-50E	FDA UDI	Class III	Active
Precision®, NA	NM-6215-BL2	FDA UDI	Class III	Active
Precision ™	SC-5312	FDA UDI	Class III	Active
Freelink™	SC-5250R	FDA UDI	Class III	Active
Bionic Navigator ™	DB-7101-204	FDA UDI	Class III	Active
Precision ™	SC-6500-03	FDA UDI	Class III	Active
Linear ™	SC-2158-50	FDA UDI	Class III	Active
Vercise™	DB-64126-US	FDA UDI	Class III	Active
Vercise™ DBS	DB-5132-S	FDA UDI	Class III	Active
Precision™	M200/205	FDA UDI	Class III	Active
Bionic Navigator™	DB-7101-204-W10	FDA UDI	Class III	Active
Precision ®	sc-5110R	FDA UDI	Class III	Active
Linear™ 3-4	SC-2352-50	FDA UDI	Class III	Active
Vercise™	DB-6300-C	FDA UDI	Class III	Active
Precision ™	SC-5110	FDA UDI	Class III	Active
Precision®, NA	NM-6215-ORG	FDA UDI	Class III	Active
Precision™ Montage™ MRI	SC-1200	FDA UDI	Class III	Active
Precision®, NA	NM-6215-GRN	FDA UDI	Class III	Active
Vercise ™ DBS	DB-5290	FDA UDI	Class III	Active
Vercise™ Cartesia™	DB-2202-45	FDA UDI	Class III	Active
Precision Spectra ™	SC-5232	FDA UDI	Class III	Active
Precision ™ OMG™	SC-9305	FDA UDI	Class III	Active
Precision™	SC-9004-70	FDA UDI	Class III	Active
Precision™	SC-4275	FDA UDI	Class III	Active
Precision ™	SC-9218-55E	FDA UDI	Class III	Active
Precision®, NA	NM-6215-LAV	FDA UDI	Class III	Active
Precision Spectra™	SC-5532-1	FDA UDI	Class III	Active
Precision ®	sc-6350	FDA UDI	Class III	Active
Precision™	SC-6412-3	FDA UDI	Class III	Active
Precision™	SC-4210	FDA UDI	Class III	Active
Artisan™	SC-8216-70	FDA UDI	Class III	Active
Linear ™	SC-2352-70E	FDA UDI	Class III	Active
Linear ™	SC-2352-50	FDA UDI	Class III	Active
Infinion™ CX	SC-2317-50E	FDA UDI	Class III	Active
Precision Spectra ™	sc-9315	FDA UDI	Class III	Active
Linear™ 3-6	SC-2366-50	FDA UDI	Class III	Active
Precision ™	sc-5312	FDA UDI	Class III	Active
Precision™	Lithium/Manganese Dioxide Battery	FDA UDI	Class III	Active
SideKick™ 2	RFK-C151020S-ZK2	FDA UDI	Class II	Active
Vercise™	DB-64125-US	FDA UDI	Class III	Active
Vercise™ Cartesia™ X	DB-2203-30	FDA UDI	Class III	Active
Vercise Genus™	DB-1232	FDA UDI	Class III	Active
Linear™ ST	SC-2218-30	FDA UDI	Class III	Active

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FDA Recalls (20)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 8, 2025	Z-2340-2025	—	open, classified	Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.
Jul 8, 2025	Z-2558-2025	—	open, classified	Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.
Jun 6, 2025	Z-2485-2025	—	open, classified	As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
Jul 17, 2024	Z-2617-2024	—	open, classified	Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.
Apr 18, 2024	Z-1890-2024	—	open, classified	Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
May 12, 2023	Z-1972-2023	—	open, classified	Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
Oct 12, 2022	Z-0230-2023	—	open, classified	Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.
May 30, 2019	Z-1698-2020	—	terminated	The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
May 30, 2019	Z-1694-2020	—	terminated	The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
May 30, 2019	Z-1696-2020	—	terminated	The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
May 30, 2019	Z-1697-2020	—	terminated	The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
May 30, 2019	Z-1695-2020	—	terminated	The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Apr 24, 2019	Z-2125-2020	—	terminated	The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Apr 24, 2019	Z-2123-2020	—	terminated	The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Apr 24, 2019	Z-2124-2020	—	terminated	The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Apr 24, 2019	Z-2122-2020	—	terminated	The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Apr 24, 2019	Z-2121-2020	—	terminated	The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Apr 24, 2019	Z-2120-2020	—	terminated	The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Apr 24, 2019	Z-2119-2020	—	terminated	The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Mar 19, 2010	Z-1409-2010	—	terminated	Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.