Z-1301-2014Class II

Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc...

Name: Z-1301-2014 Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc...
Creator: Biocardia, Inc.
Published: 2014-03-03
License: https://open.fda.gov/license/

Biocardia, Inc. / initiated 2014-03-03 / Terminated

FDA source

Biocardia, Inc. began a recall of Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is... on 2014-03-03. FDA classified it as Class II and gives the reason as "Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1301-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-03
Posted: 2014-03-27
Terminated: 2014-06-19
Recalling firm: Biocardia, Inc.
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.
Product code: DYB Introducer, Catheter
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.
FDA root cause: Other
Action: The firm, BioCardia, Inc., sent an "URGENT-VOLUNTARY MEDICAL DEVICE RECALL" letter dated March 3, 2014 its customers, hospital's Director of Risk Management, via USPS mail and priority mail to Cardiac Catheterization Laboratory. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory; quarantine the product; return the product to BioCardia and contact Customer Service at 650-226-0148 to coordinate product return; in the event you no longer have this device as a result of further distribution, identify the purchaser and notify them at once of this recall; and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via FAX to 650-631-3731 or mail to: BioCardia, Inc., 125 Shoreway Road, Suite B, San Carlos, CA 94070 as soon as possible. If you have any questions, call the Vice President, Quality Assurance at 650-226-0143.
Quantity in commerce: ~2541 - both models
Distribution: Worldwide Distribution: US (nationwide) and country of: Israel.
Product codes and lots: Catalog number MAP645 - 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1301-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1301-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-27
Z-1302-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-27

Product code DYB

K090999Class IIBiocardia Morph Sheath GuideBiocardia, Inc. / cleared 2009-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)