Boston Scientific Neuromodulation recalls

Boston Scientific Neuromodulation has 24 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 12 Aug 2026. 12 are still ongoing. 5 were reported in the last 12 months. The most frequent reason is packaging defects.

Total recalls24since 2020

Last 12 months5reported

Class I14% of total

Ongoing12latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 1Aug 2 0 0Nov 0 0 0Feb 0 0 0May 3 1 1Aug 0 0

Severity split

Class I 1 4%Class II 23 96%Class III 0 0%

Why boston scientific neuromodulation is recalled

Product types

By year

2026521%
2025313%
202428%
202314%
202214%
20201250%

Ongoing boston scientific neuromodulation recalls

12 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS I	Infinion Cx Lead Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	NY
15 Jul 2026Device	CLASS II	Intracept Access Instruments, Description recalled by Boston Scientific	Boston Scientific Neuromodulation	Sterility	Nationwide
17 Jun 2026Device	CLASS II	Boston Scientific TCN Electrodes recalled	Boston Scientific Neuromodulation	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Boston Scientific recalled	Boston Scientific Neuromodulation	Sterility	Nationwide
17 Jun 2026Device	CLASS II	Boston Scientific CSK Electrodes recalled	Boston Scientific Neuromodulation	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Vercise Deep Brain Stimulation Systems Surgical Implant recalled	Boston Scientific Neuromodulation	Device Malfunction	Nationwide

All boston scientific neuromodulation recalls, newest first

24 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS I	Infinion Cx Lead Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	NY
15 Jul 2026Device	CLASS II	Intracept Access Instruments, Description recalled by Boston Scientific	Boston Scientific Neuromodulation	Sterility	Nationwide
17 Jun 2026Device	CLASS II	Boston Scientific TCN Electrodes recalled	Boston Scientific Neuromodulation	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Boston Scientific recalled	Boston Scientific Neuromodulation	Sterility	Nationwide
17 Jun 2026Device	CLASS II	Boston Scientific CSK Electrodes recalled	Boston Scientific Neuromodulation	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Vercise Deep Brain Stimulation Systems Surgical Implant recalled	Boston Scientific Neuromodulation	Device Malfunction	Nationwide
10 Sep 2025Device	CLASS II	Superion IDS Kit Superion Indirect Decompression System recalled	Boston Scientific Neuromodulation	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS II	Burr Hole Cover Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	Nationwide
21 Aug 2024Device	CLASS II	Wavewriter Alpha recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	Nationwide
5 Jun 2024Device	CLASS II	Vercise Genus Deep Brain Stimulation recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	Nationwide
21 Jun 2023Device	CLASS II	Driver Instrument, part of the Superion Indirect recalled	Boston Scientific Neuromodulation	Foreign Material	Nationwide
23 Nov 2022Device	CLASS II	Superion¿ Indirect Decompression System (IDS) recalled	Boston Scientific Neuromodulation	Device Malfunction	Nationwide
3 Jun 2020Device	CLASS II	ArtisanTM Surgical Lead Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	CA
3 Jun 2020Device	CLASS II	The LinearTM 3-4 8 Contact Lead Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	CA
3 Jun 2020Device	CLASS II	Precision TM M8 Adapter recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	CA
3 Jun 2020Device	CLASS II	Fifty-five cm 8 Contact Extension Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	CA
3 Jun 2020Device	CLASS II	Fifty-five cm 8 Contact Extension Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Other	CA
3 Jun 2020Device	CLASS II	LinearTM 3-4 8 Contact Lead Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	CA
3 Jun 2020Device	CLASS II	Thirty-five cm 8 Contact Extension Kit recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	CA
22 Apr 2020Device	CLASS II	Nitinol Thermocouple Electrode recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	Nationwide
22 Apr 2020Device	CLASS II	Nitinol Thermocouple Electrode, 3m Cable recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	Nationwide
22 Apr 2020Device	CLASS II	Nitinol Thermocouple Electrode, 3m Cable recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	Nationwide
22 Apr 2020Device	CLASS II	Nitinol Thermocouple Electrode recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	Nationwide
22 Apr 2020Device	CLASS II	Nitinol Thermocouple Electrode recalled by Boston Scientific	Boston Scientific Neuromodulation	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.