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Boston Scientific Neuromodulation

United States·US-MF-000004703

Last updated September 17, 2026

What Boston Scientific Neuromodulation makes

The company manufactures implantable and trial electrical stimulation systems for chronic pain management and neurological conditions, including spinal cord and deep brain stimulation devices. Products include wired and wireless pulse generators, control units, leads for nerve/peripheral stimulation, intraoperative test leads, and software for device management. Examples include systems like the SideKick™ 2, Vercise™, and Superion™ for targeted nerve modulation.

These devices are classified under FDA’s Class II and Class III regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates under US regulatory oversight, adhering to requirements for electrical stimulation systems intended for chronic pain relief and neurological therapy.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

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 5 of 7

Device	Model / Reference	Registries	Class	Status
Precision™	SC-4310	FDA UDI	Class III	Active
Infinion™ CX	SC-2317-70E	FDA UDI	Class III	Active
Precision ® OMG ™	sc-9310	FDA UDI	Class III	Active
SureTek™	DB-4605-C	FDA UDI	Class III	Active
Clik™ Anchor	SC-4276	FDA UDI	Class III	Active
Click™	SC-4316	FDA UDI	Class III	Active
CoverEdge™ MRI	SC-8436-50	FDA UDI	Class III	Active
Precision™	6015425-001	FDA UDI	Class III	Active
Vercise™ DBS	DB-5250-S	FDA UDI	Class III	Active
Precision Spectra ™	NM-6310	FDA UDI	Class III	Active
Freelink™	SC-5260	FDA UDI	Class III	Active
Superion™	101-9816	FDA UDI	Class III	Active
Precision Spectra ™	sc-5532-1	FDA UDI	Class III	Active
Precision ™ Cable USB Serial	5093144-001	FDA UDI	Class III	Active
Linear™	SC-2158-50E	FDA UDI	Class III	Active
Linear ™	SC-2366-30E	FDA UDI	Class III	Active
Precision ™	SC-1010C	FDA UDI	Class III	Active
CoverEdge™ 32	SC-8336-70	FDA UDI	Class III	Active
Precision ™ Lead Blank	SC-4350-ID	FDA UDI	Class III	Active
Precision ®	sc-6358-0BK	FDA UDI	Class III	Active
Precision ®	sc-6358-1BK	FDA UDI	Class III	Active
Vercise™ Cartesia™	DB-2202-30	FDA UDI	Class III	Active
Freelink™	SC-5542-1	FDA UDI	Class III	Active
Spectra WaveWriter™	SC-1060-B	FDA UDI	Class III	Active
Precision™	SC-9208-55	FDA UDI	Class III	Active
Precision®	SC-4311	FDA UDI	Class III	Active
Precision ®	sc-6358-9BK	FDA UDI	Class III	Active
Vercise™	DB-5500-1	FDA UDI	Class III	Active
Entrada ™	SC-4220-60	FDA UDI	Class III	Active
Precision Spectra™ OMG	SC-9315	FDA UDI	Class III	Active
Precision ™	sc-6500-03	FDA UDI	Class III	Active
Precision® Epimed	SC-4210	FDA UDI	Class III	Active
Vercise ™	DB-7105-N501	FDA UDI	Class III	Active
Precision®	SC-4306	FDA UDI	Class III	Active
Linear™ 3-4	SC-2352-50E	FDA UDI	Class III	Active
CoverEdge™	SC-8336-70	FDA UDI	Class III	Active
Precision®, NA	SC-6200	FDA UDI	Class III	Active
Vertiflex™ VIP	140-9800	FDA UDI	Class III	Active
Precision ®	sc-6358-5BK	FDA UDI	Class III	Active
Precision®	SC-4400	FDA UDI	Class III	Active
Precision ™	SC-4230	FDA UDI	Class III	Active
Precision ™	SC-9208-15E	FDA UDI	Class III	Active
Vercise™	DB-7105-N21	FDA UDI	Class III	Active
Precision® Passing Elevator	SC-4230	FDA UDI	Class III	Active
Precision ™ Cable USB Serial	6015425-001	FDA UDI	Class III	Active
Linear ™	SC-2366-70E	FDA UDI	Class III	Active
Avista™ MRI	SC-2408-74	FDA UDI	Class III	Active
Linear™ 3-6	SC-2366-70	FDA UDI	Class III	Active
Precision Spectra ™	sc-6360-32	FDA UDI	Class III	Active
Precision Spectra ™	SC-5132	FDA UDI	Class III	Active

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Authorities

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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.

Boston Scientific Neuromodulation has initiated 20 recall records between March 19, 2010, and July 8, 2025, with statuses including open, classified, and terminated. The reasons cited involve incorrect labeling of expiration dates on spinal cord stimulation leads and related components, device resets in deep brain stimulation systems, wire breaks in rechargeable implantable pulse generators, difficulties with retaining clip mechanisms in burr hole cover kits, inconsistent performance in devices and instruments, weld breakage in indirect decompression systems, incorrect packaging of instructions for use, and pending updates to procedural instructions regarding potential instrument tip breaks during implantation.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.