Recall Z-3213-2026— PI CARDIA LTD
Class II · Ongoing
Class II FDA medical device recall by PI CARDIA LTD, initiated 2026-07-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US. Reason: Transfemoral catheter, positing arm may detached due to weld issue..
- Recalling firm
- PI CARDIA LTD
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-06
- Firm location
- Rehovot, N/A, Israel
Product description
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Reason for recall
Transfemoral catheter, positing arm may detached due to weld issue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.