Morph AccessPro Steerable Introducer — Class II medical device recall Z-1301-2014
Terminated recall by Biocardia, Inc., reported 2014-04-02, distributed nationwide. Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, wh
| Recall number | Z-1301-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocardia, Inc., San Carlos, CA, United States |
| Recall initiated | 2014-03-03 |
| Classified | 2014-03-27 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2014-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | IL |
| Quantity | 2,541 |
| Reason classes | specification failure |
| Lot numbers | 1037, 1048, 1055, 1059, 1069, 1073, 1074, 1079, 1092, 1095, 1115, 1118, 1121, 1125, 1128, 1130, 1134, 1147, 1155, 1164, 1168, 1169, 1173, 1177, 1184, 1190 |
| Model numbers | MAP645 |
Product
Morph AccessPro Steerable Introducer; 6F Introducer, 45 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.
Reason for recall
Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
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-1301-2014. 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.