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FDAFDA · Food and drugs·Recall number Z-0132-2025

Vanta Implantable Neurostimulator (INS), Model 977006

Published October 23, 2024 · Recall initiated: August 21, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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 to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Medtronic Neuromodulation
Distributor
Worldwide distribution.
Lot
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, NMS500444H, NMS500445H, NMS500446H, NMS500447H, NMS500448H, NMS500449H, NMS500450H, NMS500451H, NMS500453H, NMS500454H, NMS500455H, NMS500456H, NMS500457H, NMS500458H, NMS500459H, NMS500460H, NMS500462H, NMS500463H, NMS500464H, NMS500465H, NMS500466H, NMS500467H, NMS500468H, NMS500469H, NMS500470H, NMS500471H, NMS500472H, NMS500473H, NMS500474H, NMS500475H, NMS500476H, NMS500479H, NMS500480H, NMS500481H, NMS500482H, NMS500483H, NMS500485H, NMS500486H, NMS500487H, NMS500489H, NMS500490H, NMS500491H, NMS500492H, NMS500515H, NMS500516H, NMS500517H, NMS500521H, NMS500522H, NMS500523H, NMS500525H, NMS500527H, NMS500528H, NMS500529H, NMS500531H, NMS500532H, NMS500533H, NMS500534H, NMS500535H, NMS500536H, NMS500537H, NMS500538H, NMS500539H, NMS500540H, NMS500542H, NMS500543H, NMS500545H, NMS500546H, NMS500547H, NMS500548H, NMS500550H, NMS500551H, NMS500552H, NMS500553H, NMS500554H, NMS500555H, NMS500556H, NMS500557H, NMS500558H, NMS500560H, NMS500561H, NMS500562H, NMS500563H, NMS500564H, NMS500566H, NMS500568H, NMS500569H, NMS500570H, NMS500572H, NMS500573H, NMS500574H, NMS500575H, NMS500576H, NMS500578H, NMS500579H, NMS500584H, NMS500585H, NMS500586H, NMS500587H, NMS500588H, NMS500592H, NMS500608H, NMS500617H, NMS500622H, NMS500626H, NMS500629H, NMS500631H, NMS500632H, NMS500633H, NMS500635H, NMS500636H, NMS500637H, NMS500638H, NMS500639H, NMS500640H, NMS500641H, NMS500645H, NMS500646H, NMS500647H, NMS500648H, NMS500649H, NMS500650H, NMS500651H, NMS500654H, NMS500655H, NMS500656H, NMS500659H, NMS500660H, NMS500661H, NMS500663H, NMS500666H, NMS500667H, NMS500669H, NMS500671H, NMS500672H, NMS500673H, NMS500674H, NMS500677H, NMS500679H, NMS500680H, NMS500681H, NMS500682H, NMS500683H, NMS500684H, NMS500685H, NMS500687H, NMS500688H, NMS500689H, NMS500690H, NMS500691H, NMS500692H, NMS500693H, NMS500694H, NMS500697H, NMS500698H, NMS500699H, NMS500701H, NMS500702H, NMS500703H, NMS500704H, NMS500705H, NMS500708H, NMS500710H, NMS500711H, NMS500714H, NMS500715H, NMS500716H, NMS500717H, NMS500719H, NMS500720H, NMS500721H, NMS500722H, NMS500723H, NMS500724H, NMS500725H, NMS500726H, NMS500727H, NMS500728H, NMS500730H, NMS500731H, NMS500733H, NMS500734H, NMS500735H, NMS500736H, NMS500737H, NMS500738H, NMS500739H, NMS500740H, NMS500741H, NMS500743H, NMS500744H, NMS500746H, NMS500747H, NMS500748H, NMS500749H, NMS500751H, NMS500752H, NMS500753H, NMS500754H, NMS500757H, NMS500759H, NMS500760H, NMS500761H, NMS500762H, NMS500764H, NMS500765H, NMS500767H, NMS500768H, NMS500771H, NMS500775H,
Risk classification
Class II
Area (FDA)
device
Country
United States

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