Facility

PI-CARDIA LTD

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3030471525
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	David Fikes 5 Rehovot Central, IL 76328
Registration status	Active · expires 2026
Parent company	Pi-Cardia LtD (owner-operator 10091623)
Brand names	ShortCut

Activity by year

Recalls (1)

Devices registered here (1)

Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Product code SCZ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1254

Recalls & enforcement

Class IIOngoing2026-07-06
Transfemoral catheter, positing arm may detached due to weld issue.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “PI-CARDIA LTD (FEI 3030471525) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3030471525-pi-cardia-ltd/

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