Class II — Biocardia, Inc.
| Recalling firm | BioCardia |
|---|---|
| Registered facility | BIOCARDIA, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Tyvek packaging may be worn, causing loss of package integrity. |
| Product | MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature. |
| Quantity | 11 units |
| Distribution | US Distribution including the states of FL, MA, WY. OH, MI and KS. |
| Initiated | 2014-02-07 |
| Classified | 2014-02-19 |
| Terminated | 2014-04-03 |
| Recall number | Z-0991-2014 |
| 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-0991-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67492/
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