Every recall we track for Boston Scientific Neuromodulation Corporation — 24 in all — plus the complaints and injury reports the public filed about them.
Boston Scientific recalls INFINION CX lead kits (50cm and 70cm models) due to potential lead fractures causing inadequate spinal stimulation. Affected users should contact for repair or replacement.
Boston Scientific recalls TCN Electrodes (TCN-5 to TCN-20 models) due to potential performance issues. Affected devices may not function as intended, but no injuries reported. Consumers should contact Boston Scientific for details.
Boston Scientific recalls SC-4318 Clik X Anchor due to sterile anchors lacking sterility assurance. Affected units have specific model and lot numbers. Consumers should contact the company for details.
Boston Scientific recalls CSK Electrodes with specific model numbers due to potential performance issues. Affected units may not function as intended, but no injuries reported. Consumers should check model details and contact for guidance.
Boston Scientific recalls Intracept Access Instruments (RLV0035, RLV0045, RLV0055, RLV0065, RLV0075) due to potential sterile barrier breach in the outer tray seal, which could lead to severe infection. Affected units have specific lot numbers and expiration dates.
Boston Scientific recalls Vercise Deep Brain Stimulation Systems with wire breaks that prevent proper function, risking loss of therapy and symptoms return. Affected units have specific UDI-DI numbers.
Boston Scientific recalls Burr Hole Cover Kits (REF: M365DB4600C0 and M365DB4605C0) for potential procedure delays or additional surgery due to locking mechanism issues in Deep Brain Stimulation systems.
Boston Scientific recalls Superion Indirect Decompression System kits (8mm-16mm) due to inconsistent performance, including breakage of instruments and implants. Affected units have specific lot/batch numbers listed in the recall notice.
Boston Scientific recalls WAVEWRITER ALPHA spinal cord stimulation devices with specific model numbers due to potential temporary loss of therapy causing discomfort and possible surgical intervention requests. Affected units have unique reference codes and serial numbers.
Boston Scientific recalls Vercise Genus Deep Brain Stimulation implantable pulse generators with specific model numbers due to potential device reset during charging, which may cause temporary loss of stimulation and worsened symptoms.
Boston Scientific recalls Driver Instrument (REF: 102-9800) used in Superion Indirect Decompression System. Excessive force during implant may cause tip breaks, leading to metal fragments that could cause injury if not removed. MRI scans are unsafe if fragments remain.
Boston Scientific recalls Superion Indirect Decompression System models 101-9808, 01-9812, and 101-9814 due to potential spindle cap weld breakage that may prevent proper device deployment during surgery.
Boston Scientific recalls certain Nitinol Thermocouple Electrodes (TCN-10) due to incorrect Instructions for Use (IFU) packaging. Affected units have specific lot numbers and GTIN. Consumers should contact the company for correction.
Boston Scientific recalls certain Nitinol Thermocouple Electrodes due to incorrect Instructions for Use packaging. These electrodes are for RF heat lesioning of nerve tissue. Affected units have specific lot numbers and GTIN.
Boston Scientific recalls certain Nitinol Thermocouple Electrodes due to incorrect Instructions for Use packaging. This may affect safe medical use of the device for nerve pain treatment.
Boston Scientific recalls certain Nitinol Thermocouple Electrodes (TCN-15) due to incorrect Instructions for Use packaging. This may affect safe medical use. Affected units have specific lot numbers.
Boston Scientific recalls certain Nitinol Thermocouple Electrodes (5cm) due to incorrect Instructions for Use packaging. This may lead to improper use of the device for nerve pain treatment.
Boston Scientific recalls Artisan 70cm 2x8 Surgical Lead Kits with incorrect use by dates. No health risks expected. Consumers should check product labels for part number M365SC8216700 and serial numbers 632107 or 645608.
Boston Scientific recalls certain spinal cord stimulation leads with incorrect use by dates. No health risks expected. Consumers should check product labels for part number M365SC2352700.
Boston Scientific recalls Precision TM M8 Adapter (part M365SC9218150) due to incorrect use by date on label. No health risks expected. Affected units include specific serial numbers for spinal cord pain management devices.
Boston Scientific recalls 55cm spinal cord stimulation extension kits with incorrect use by dates. No health risks expected but removal advised due to potential labeling error.
Boston Scientific recalls 55cm 8-contact DBS extension kits with incorrect use-by dates. No health risks expected. Affected units have specific serial numbers.
Boston Scientific recalls certain spinal cord stimulation leads due to an incorrect use by date label. No health risks expected. Affected units include specific part numbers and serial numbers.
Boston Scientific recalls 35cm spinal cord stimulation extension kits with incorrect use by dates. No health risks expected from this labeling error.
