Reported Sep 23, 2026 · Ongoing · Updated Sep 29, 2026
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Pi Cardia Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PI CARDIA LTD · 5, David Pikes St · Rehovot, N/A · N/A
Is this the product you have?
- Pi-Cardia Inc
- ShortCut REFZ-A-20.003-US
- Lot codes and dates
- UDI-DI - (01)7290020101242 All serial
- numbers in the affected lot SCUS-00013
SC919SC920SC921SC923SC924SC925SC926SC927SC928SC929SC930SC931SC932SC933SC934SC935SC936SC937SC938SC939SC940SC941SC942SC943SC944SC945SC946SC947SC948SC949SC950SC951SC952SC953SC954SC956SC957SC958SC960SC961SC962SC963SC964SC966SC967 and SC968
- Amount recalled
- 46 units
Where it was sold
Why it was recalled
Transfemoral catheter, positing arm may detached due to weld issue.
This product could cause temporary or reversible health problems — stop using it.
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