Z-0991-2014Class II

MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged...

Name: Z-0991-2014 MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged...
Creator: Biocardia, Inc.
Published: 2014-02-07
License: https://open.fda.gov/license/

Biocardia, Inc. / initiated 2014-02-07 / Terminated / root cause: manufacturing process

FDA source

Biocardia, Inc. began a recall of MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic... on 2014-02-07. FDA classified it as Class II and gives the reason as "Tyvek packaging may be worn, causing loss of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0991-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-07
Posted: 2014-02-19
Terminated: 2014-04-03
Recalling firm: Biocardia, Inc.
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.
Product code: DYB Introducer, Catheter
Reason for recall: Tyvek packaging may be worn, causing loss of package integrity.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Sales Representative called each affected hospital on February 7, 2014, to notify them of the recall. BioCardia has initiated a recall of Morph AccessPro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Sales representatives contacted hospital sites identified in Attachment 3 by telephone. Script provided as follows: "BioCardia has initiated a recall of Morph Access Pro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Our records indicate that we sold you. The recall is limited to these units in this lot sold to you. We would like to confirm if you still have the unit(s). If you do, we ask that you quarantine the unit(s) and our customer service department will contact you to coordinate the return of the unit(s)." For further questions please call (650) 226-0133.
Quantity in commerce: 11 units
Distribution: US Distribution including the states of FL, MA, WY. OH, MI and KS.
Product codes and lots: Catalog number MAP690; Lot numbers 01162 and 01186.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0991-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0991-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19

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)