Inspire Medical Systems Inc. recalls Inspire Model 3028, IV Implantable Pulse Generator
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,
Read the official notice →- Date
- 2024-07-03
- Country
- United States
- Brand
- Inspire Medical Systems
- Product
- Inspire Model 3028, IV Implantable Pulse Generator
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide and the country of Germany.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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