Official recall notice
FDA DeviceClass IINotable
FDA Recall: Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
- Recall date
- 2026-09-23
- Brand
- PI CARDIA LTD
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Transfemoral catheter, positing arm may detached due to weld issue.
Product description
Transfemoral catheter, positing arm may detached due to weld issue.
Affected products
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.