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FDA Medical Device Recalls (openFDA)

Medtronic Cardiovascular Surgery-the Heart Valve Division: 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.

Recall number
Z-2623-2014
Recalling firm
Medtronic Cardiovascular Surgery-the Heart Valve 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.
Status
Terminated
Initiated
2014-08-15
Posted
2014-09-11
Terminated
2014-11-06
Reason
Medtronic has decided to discontinue production and distribution of this low-volume product.
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 RS.CFQFCA@Medtronic.com or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.
Quantity
2 units
Distribution
Distributed in the states of MD and TX.
Lot, serial or model codes
Serial Numbers: B146341, B146350
510(k) numbers
not on file
PMA numbers
["P870078"]
Product code
DYE
Firm FEI
2025587
Firm city
Santa Ana
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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