Inspire Medical Systems Inc.: Inspire Model 3028, IV Implantable Pulse Generator

Hazard

There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,

Details from the source

Reason for recall: There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG, Distribution: Worldwide distribution - US Nationwide and the country of Germany. Quantity: 24 devices Lot/code info: US: UDI/DI 0855728005915, Serial Numbers: AIR324492C, AIR324500C, AIR324506C, AIR324510C, AIR324518C, AIR324523C, AIR324493C, AIR324502C, AIR324507C, AIR324511C, AIR324520C, , AIR324494C, AIR324503C, AIR324508C, AIR324515C, AIR324521C, AIR324496C, AIR324504C, AIR324509C, AIR324517C, AIR324522C; Europe: UDI/DI 10855728005847, Serial Numbers: AIR324497C, AIR324499C, AIR324505C

UPC codes

0855728005915, 10855728005847

Source

Official record: FDA (Device enforcement) ↗

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