FDA-Device2026-09-23Class IIPROCESSING DEFECT
Pi-Cardia ShortCut transfemoral catheter recalled for potential positioning arm detachment
What this means
Pi-Cardia Inc. identified a weld issue in the ShortCut transfemoral catheter that may cause the positioning arm to detach during use. The defect affects 46 units in specific serial number lots distributed across eight U.S. states. No injuries have been reported to date.
- If you have a ShortCut catheter with a serial number listed in lot SCUS-00013 (SC919–SC968), do not use it
- Contact Pi-Cardia Inc. or your hospital's medical device supplier for instructions on device replacement or return
- Notify your healthcare provider if you or a patient has already received this device
The agency's original wording
Hazard
Transfemoral catheter, positing arm may detached due to weld issue.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Affected count
46 units
Manufactured in
5, David Pikes St, N/A, Rehovot, N/A, Israel
Products
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3213-2026Want us to check the next one for you?
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