FDA Enforcement
Class II
Ongoing
Medtronic CareLink Encore 29901 Programmer
Recall: Z-0407-2019
·
Reported November 14, 2018
Enforcement
- Recall Number
- Z-0407-2019
- Event ID
- 81300
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 14, 2018
- Initiation Date
- October 2, 2018
- Classification Date
- November 8, 2018
- Address
- 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391, United States
Description
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.
Code Info
All Serial Numbers
Distribution
Worldwide
Quantity
4072 units