BIOCARDIA, INC.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (2)
Devices registered here (1)
- Catheter, Intravascular, DiagnosticProduct code DQO (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1200
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.
FDA inspections (2)
- NAI2023-04-10No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
- VAI2016-03-04Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
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. “BIOCARDIA, INC. (FEI 3003610571) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003610571-biocardia-inc/
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