Z-3213-2026 Class II Ongoing
FDA device recall Z-3213-2026 was initiated by PI CARDIA LTD on July 6, 2026 and is designated Class II. Reason for recall: Transfemoral catheter, positing arm may detached due to weld issue. The recall status is ongoing. Affected quantity: 46 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product Description
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Reason for Recall
Transfemoral catheter, positing arm may detached due to weld issue.
Distribution Pattern
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Code Information
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.