Inspire Model 3028, IV Implantable Pulse Generator

FDA device recall Z-2159-2024 · posted 2024-06-21 · Open, Classified

Recall details

Recalling firm

Inspire Medical Systems Inc.

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,

Action taken

Inspire Medical systems issued an URGENT Medical Device Correction notice to the affected healthcare providers on 05/16/2024 via FedEx overnight. The notice explains the potential problem with the device and risk to the patient and recommends the following actions: We recommend the following actions: " Notify affected patients of this voluntary recall. " Schedule your patient for a monitoring visit to confirm their Inspire therapy is working as intended through waveform and impedance analysis. Monitor patients for reports of variation in stimulation, a lack of therapy effectiveness, or an inability to turn on therapy. " Continue with routine monitoring and conduct waveform and impedance analysis at every routine office visit, as IPG issue may be non-invasively identified with basic waveform and impedance testing. " If abnormal waveforms or impedances are observed, record impedance values at 1.5V, 2.0V, 2.5V, 3.0V and 3.5V. o Let the patient know they will feel 3 short pulses of stimulation. o Some of these stimulation pulses may feel strong. This is normal. " Contact your Inspire representative for additional diagnostic testing and troubleshooting recommendations. For additional questions: please contact your Inspire representative or the Inspire Quality team at ProductRecalls@inspiresleep.com.

Root cause

Process control

Status

Open, Classified

Product code

MNQ

Quantity affected

24 devices

Distribution

Worldwide distribution - US Nationwide and the country of Germany.

Date initiated

2024-05-16

Date posted

2024-06-21

Location

Golden Valley, MN