Z-2623-2014Class II

Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction...

Name: Z-2623-2014 Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction...
Creator: Medtronic Cardiovascular Surgery-the Heart Valve Division
Published: 2014-08-15
License: https://open.fda.gov/license/

Medtronic Heart Valves Division / initiated 2014-08-15 / Terminated / root cause: design

FDA source

Medtronic Cardiovascular Surgery-the Heart Valve Division began a recall of Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an... on 2014-08-15. FDA classified it as Class II and gives the reason as "Medtronic has decided to discontinue production and distribution of this low-volume product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2623-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-15
Posted: 2014-09-11
Terminated: 2014-11-06
Recalling firm: Medtronic Heart Valves Division
Product: Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
Product code: DYE Replacement Heart-Valve
Reason for recall: Medtronic has decided to discontinue production and distribution of this low-volume product.
Root cause tag: design
FDA root cause: Component design/selection
Action: An Urgent Medical Device Recall letter, dated August, 2014, was sent to customers on 8/15/14 for specific serial numbers of Hancock Apical Left Ventricle Connector, model H174Axx, devices. This recall is the result of a decision by Medtronic to discontinue sales of this low volume product, in lieu of fulfilling new regulatory requirements to maintain its distribution in the United States. Customers are instructed to quarantine and return all listed product in their inventory to Medtronic and contact customer service at (800) 854-3570. Customers are instructed to complete the attached customer confirmation certificate and e-mail it to [email protected] or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.
Quantity in commerce: 2 units
Distribution: Distributed in the states of MD and TX.
Product codes and lots: Serial Numbers: B146341, B146350

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2623-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2623-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-11

Product code DYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)