FDA Device recall Z-1302-2014
Morph AccessPro Steerable Introducer
- FDA Device
- Class II
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class II recall of Morph AccessPro Steerable Introducer by Biocardia, citing firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1302-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-03 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biocardia |
| Distribution | US |
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.
Reason
Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Identifiers
| code_info | Catalog number MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148…Catalog number MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1302-2014%22
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