Company: Medtronic Inc.
Date of Enforcement Report: 11/8/2018
Class II:
PRODUCT
Medtronic CareLink 2090 Programmer and Encore 29901 Programmer
Recall Number: Z-0406-2019 (2090), Z-0407-2019 (29901)
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/MANUFACTURER
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN on 10/2/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
30172 units
DISTRIBUTION
Worldwide
You can find all recent FDA Enforcement Reports on the FDA.gov website: www.accessdata.fda.gov