MORPH ACCESSPRO Steerable Introducer — Class II medical device recall Z-0991-2014
Terminated recall by Biocardia, Inc., reported 2014-02-26, distributed in FL, KS, MA, MI, OH, WY. Tyvek packaging may be worn, causing loss of package integrity.
| Recall number | Z-0991-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocardia, Inc., San Carlos, CA, United States |
| Recall initiated | 2014-02-07 |
| Classified | 2014-02-19 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2014-04-03 |
| Distributed | FL, KS, MA, MI, OH, WY |
| Quantity | 11 units |
| Reason classes | packaging |
| Lot numbers | 01162, 01186 |
| Model numbers | MAP690 |
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.
Reason for recall
Tyvek packaging may be worn, causing loss of package integrity.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0991-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.