Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink Encore 29901 Programmer
- Recall date
- October 2, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0407-2019
- FDA classification
- Class II
- Brand / firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Sold / distributed
- Worldwide
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medtronic CareLink Encore 29901 Programmer
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