BioCardia
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (1)
- BIOCARDIA, INC. FEI 3003610571 · CA
Recalls & enforcement
- Class IITerminated2014-03-03Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
- Class IITerminated2014-02-07Tyvek packaging may be worn, causing loss of package integrity.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “BioCardia — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9038602-biocardia/
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