Rehovot, N/A, Israel
PI CARDIA LTD recalls
1 recall recorded since 2018, most recently on 6 July 2026. 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
- 6 July 2026
- Reason
- Transfemoral catheter, positing arm may detached due to weld issue.
- Distribution
- US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3213-2026
- Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
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.