FDA Medical devices recall ·
Vanta Implantable Neurostimulator (INS), Model 977006 recall
- Recall number
- Z-0132-2025
- Date
- (initiated August 21, 2024)
- Company / brand
- Medtronic Neuromodulation
7000 Central Ave Ne, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11789 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Vanta Implantable Neurostimulator (INS), Model 977006
Why was it recalled?
Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00763000411923, Serial Numbers: NMS500122H, NMS500123H, NMS500130H, NMS500135H, NMS500159H, NMS500190H, NMS500191H, NMS500194H, NMS500201H, NMS500309H, NMS500310H, NMS500312H, NMS500313H, NMS500314H, NMS500315H, NMS500316H, NMS500317H, NMS500318H, NMS500319H, NMS500320H, NMS500321H, NMS500322H, NMS500323H, NMS500326H, NMS500327H, NMS500329H, NMS500330H, NMS500332H, NMS500333H, NMS500334H, NMS500335H, NMS500336H, NMS500337H, NMS500339H, NMS500340H, NMS500341H, NMS500343H, NMS500344H, NMS500345H, NMS500347H, NMS500348H, NMS500350H, NMS500351H, NMS500356H, NMS500357H, NMS500358H, NMS500359H, NMS500360H, NMS500361H, NMS500363H, NMS500364H, NMS500365H, NMS500366H, NMS500368H, NMS500369H, NMS500370H, NMS500371H, NMS500372H, NMS500373H, NMS500374H, NMS500375H, NMS500376H, NMS500377H, NMS500378H, NMS500379H, NMS500380H, NMS500382H, NMS500383H, NMS500385H, NMS500386H, NMS500387H, NMS500388H, NMS500389H, NMS500390H, NMS500391H, NMS500392H, NMS500393H, NMS500394H, NMS500395H, NMS500396H, NMS500397H, NMS500398H, NMS500399H, NMS500402H, NMS500403H, NMS500405H, NMS500407H, NMS500409H, NMS500410H, NMS500411H, NMS500412H, NMS500413H, NMS500414H, NMS500415H, NMS500416H, NMS500417H, NMS500418H, NMS500419H, NMS500420H, NMS500421H, NMS500422H, NMS500423H, NMS500424H, NMS500425H, NMS500426H, NMS500427H, NMS500428H, NMS500429H, NMS500430H, NMS500431H, NMS500432H, NMS500433H, NMS500434H, NMS500435H, NMS500437H, NMS500438H, NMS500439H, NMS500440H, NMS500441H, NMS500442H, NMS500443H, NMS500444
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0132-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.