FDA recall Z-3213-2026

PI CARDIA LTD · Class II · device

Product

Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

Reason for recall

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.

Key facts

Status
Ongoing
Initiation date
2026-07-06
Report date
2026-09-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rehovot, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3213-2026