Heartware, Inc.: HeartWare HVAD Outflow Graft, REF MCS1725OG

Recall number

Z-2196-2021

Recalling firm

Heartware, Inc.

Product

HeartWare HVAD Outflow Graft, REF MCS1725OG

Status

Open, Classified

Initiated

2021-06-03

Posted

not on file

Terminated

not on file

Reason

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

Root cause

Unknown/Undetermined by firm

Action

In the United States, beginning 03-Jun-2021, this notice was delivered to Risk Managers via UPS 2-day delivery in the United States as well as through verbal and in person follow ups from the Medtronic field staff. In addition, a courtesy copy was sent to all implanting and following physicians via UPS 2-day delivery. Finally, an e-mail notice was sent as a courtesy copy to all consignees who had opted into communication from Medtronic. Medtronic began an additional communication on 7 July 2021 to all consignees who, according to Medtronic records had unexpired product (see Attachment D Product List) at the time of the initial communication on 03-JUN-2021. The consignees are being asked to confirm receipt of the notification and return all affected product within their possession. This communication also stresses the importance of not returning peripherals (batteries, cables, patient packs, etc.) and surgical tool kits if they still have patients on support. In the US, this communication was delivered to VAD Coordinators via UPS 2-day delivery. Outside of the United States, beginning 07-JUL-2021 this communication will be delivered to consignees.

Quantity

459 units

Distribution

Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.

Lot, serial or model codes

GTIN: 00888707007627, 00888707007634 All serial numbers

510(k) numbers

not on file

PMA numbers

["P100047"]

Product code

DSQ

Firm FEI

3007042319

Firm city

Miami Lakes

Firm state

FL

Firm country

not on file

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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