Stenlose, Denmark
Mermaid Medical A/S recalls
1 recall recorded since 2018, most recently on 1 May 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 May 2024
- Reason
- Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, MO, CO, NC, TX, MA, GA, FL, IL, IN, MD, PA, VA, and the country of Chile.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2213-2024
- The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends en
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.