FDAClass IApril 14, 2021

Medtronic HVAD Monitor Data Cable recall

Medtronic HVAD Monitor Data Cable, Product Number: 1575

Why was Medtronic HVAD Monitor Data Cable recalled?

There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot codes

Product
Medtronic HVAD Monitor Data Cable, Product Number: 1575
Recalling firm
Heartware, Inc.
Quantity
1337 units (1110 US)
Distribution
Worldwide
Recall date
April 14, 2021
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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