Class IIDeviceOngoing

PI CARDIA LTD

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

Reason for recall

Transfemoral catheter, positing arm may detached due to weld issue.

Details

Recall number: Z-3213-2026
Event ID: 99664
Recall initiated: Jul 6, 2026
Classified: Sep 17, 2026
Reported: Sep 23, 2026
Quantity: 46 units
Distribution: US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Rehovot, N/A, Israel
Lot / code info: 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.