Recall Z-0407-2019— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2018-10-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic CareLink Encore 29901 Programmer. Reason: 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..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-10-02
- Firm location
- Mounds View, MN, United States
Product description
Medtronic CareLink Encore 29901 Programmer
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.