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Class IIOngoing

PI CARDIA LTD recalls Pi-Cardia Inc

Recall date · record updated Sep 23, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
PI CARDIA LTD
Reason
Transfemoral catheter, positing arm may detached due to weld issue.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99664…

Products

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

    Codes/lots: 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.Quantity: 46 unitsRecall no. Z-3213-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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