Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US recall (PI CARDIA LTD)
Medical deviceClass IIOngoing
Summary: PI CARDIA LTD is recalling Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US. Reason: Transfemoral catheter, positing arm may detached due to weld issue.
What is being recalled
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Why
Transfemoral catheter, positing arm may detached due to weld issue.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York. (states named: California, Delaware, Kansas, Massachusetts, New Hampshire, New York, Pennsylvania, Utah)
How to tell if yours is affected
UDI-DI - (01)7290020101242 All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926, SC927, SC928, SC929, SC930, SC931, SC932, SC933, SC934, SC935, SC936, SC937, SC938, SC939, SC940, SC941, SC942, SC943, SC944, SC945, SC946, SC947, SC948, SC949, SC950, SC951, SC952, SC953, SC954, SC956, SC957, SC958, SC960, SC961, SC962, SC963, SC964, SC966, SC967 and SC968.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3213-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 6, 2026 |
| Reported | September 23, 2026 |
| Company | PI CARDIA LTD |
| Company location | Rehovot, N/A, Israel |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 46 units |
More recalls from PI CARDIA LTD · all medical device recalls · recalls from July 2026