FDA recall Z-2159-2024

Product

Inspire Model 3028, IV Implantable Pulse Generator

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.

Key facts

Status

Ongoing

Initiation date

2024-05-16

Report date

2024-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Golden Valley, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2024