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

Medical DevicesSource: FDA (device) · Date: 2026-09-23

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
PI CARDIA LTD
Product
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Reason / hazard
Transfemoral catheter, positing arm may detached due to weld issue.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Recall initiated
2026-07-06
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.
Product quantity
46 units
Voluntary mandated
Voluntary: Firm initiated
City
Rehovot
State
N/A
Country
Israel
Event id
99664
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