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SenSight™
MEDTRONIC, INC. · Model B3400095 · UDI-DI 00763000426491
0
510(k) clearances
53,246
Adverse events (733 deaths)
46
Recalls
31
Facilities
Description
EXT B3400095 SENSIGHT NO MKR EMAN LJ53
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-13 | Medtronic Neuromodulation | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. |
| 2026-05-13 | Medtronic Neuromodulation | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. |
| 2025-10-06 | Abbott Medical | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable P |
| 2024-09-24 | Medtronic Neuromodulation | A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an " |
| 2024-05-22 | Abbott Medical | Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting |
| 2024-05-22 | Abbott Medical | Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting |
| 2024-05-22 | Abbott Medical | Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting |
| 2024-05-22 | Abbott Medical | Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting |
| 2024-05-16 | Abbott Medical | Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 day |
| 2024-05-15 | Medtronic Neuromodulation | Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.