Class II — Biocardia, Inc.
| Recalling firm | BioCardia |
|---|---|
| Registered facility | BIOCARDIA, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. |
| Product | Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature. |
| Quantity | ~2541 units - both catalog numbers. |
| Distribution | Worldwide Distribution: US (nationwide) and country of: Israel. |
| Initiated | 2014-03-03 |
| Classified | 2014-03-27 |
| Terminated | 2014-06-19 |
| Recall number | Z-1302-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biocardia, Inc. (Z-1302-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67712/
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