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Hancock Apical Left Ventricle Connector, Model No. H174Axx… recallZ-2623-2014 · Medtronic Cardiovascular Surgery-the Heart Valve Division · initiated Aug 15, 2014

Class II Terminated All recalls posted in September 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Cardiovascular Surgery-the Heart Valve Division or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Medtronic has decided to discontinue production and distribution of this low-volume product.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-2623-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 15, 2014
Posted by the FDA
Sep 11, 2014
Recalling firm
Medtronic Cardiovascular Surgery-the Heart Valve Division
Quantity
2 units
Product code
DYE
FDA submissions
P870078
Distribution
Distributed in the states of MD and TX.

Product description

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.

Code information (models, lots, serial numbers)

Serial Numbers: B146341, B146350

Other devices under the same FDA submission

9 devices cleared under P870078 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page