Medtronic Neuromodulation: Vanta Implantable Neurostimulator (INS), Model 977006

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.

Details from the source

Reason for recall: Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements. Distribution: Worldwide distribution. Quantity: 11789 units Lot/code info: 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

UPC codes

00763000411923

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.