Pi-Cardia ShortCut Device
The ShortCut transfemoral catheter has a detaching positioning arm due to a weld issue.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
PI CARDIA LTD, of Rehovot, Israel, began a recall of the Pi-Cardia Inc. ShortCut, REF Z-A-20.003-US, on July 6, 2026, after the agency identified that the transfemoral catheter's positioning arm may detach due to a weld issue. The recall involves 46 units and was added to the FDA's Enforcement Report on September 17, 2026. Distribution was nationwide in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- UDI-DI
- 7290020101242
- Lot
- All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Event ID
- 99664
- Recall No.
- Z-3213-2026
- Company
- PI CARDIA LTDRehovot, Israel
- Hazard
- Device defect
- Quantity recalled
- 46 units
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
