FDAClass IINovember 14, 2018

Medtronic CareLink Encore 29901 Programmer recall: Software Issue

Medtronic CareLink Encore 29901 Programmer

Why was Medtronic CareLink Encore 29901 Programmer recalled?

Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

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 Serial Numbers

Product
Medtronic CareLink Encore 29901 Programmer
Recalling firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity
4072 units
Distribution
Worldwide
Recall date
November 14, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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