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HeartWare HVAD Driveline Extension Cable, REF 100US recallZ-2193-2021 · Heartware, Inc. · initiated Jun 3, 2021

Open, Classified

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 Heartware, Inc. 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 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.

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

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.

Recall details

Recall number
Z-2193-2021
Status
Open, Classified
Initiated by the company
Jun 3, 2021
Recalling firm
Heartware, Inc.
Quantity
443 units
Product code
DSQ
FDA submissions
P100047
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.

Product description

HeartWare HVAD Driveline Extension Cable, REF 100US

Code information (models, lots, serial numbers)

GTIN: 00888707000024 All serial numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

33 devices cleared under P100047 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88197).

Sources and updates

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