Device recall
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Recall number
- Z-3213-2026
- Event id
- 99664
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- PI CARDIA LTD
- Report date
- Sep 23, 2026
- Posted
- Sep 17, 2026
- Initiated
- Jul 6, 2026
- Center classification date
- Sep 17, 2026
- Product code
- SCZ
- Device type
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Reason
- Transfemoral catheter, positing arm may detached due to weld issue.
- Root cause
- Process control
- Quantity
- 46 units
- 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.
- Distribution
- US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Rehovot, N/A, Israel