Date Initiated by Firm |
October 02, 2018 |
Create Date |
November 08, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0406-2019 |
Recall Event ID |
81300 |
PMA Number |
P890003S398 |
Product Classification |
Pacemaker/icd/crt non-implanted components - Product Code OSR
|
Product |
Medtronic CareLink 2090 Programmer |
Code Information |
All Serial Numbers |
Recalling Firm/ Manufacturer |
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 8200 Coral Sea St Ne Mounds View MN 55112-4391
|
For Additional Information Contact |
Medtronic Instruments 800-638-1991
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Software design |
Action |
The firm began disseminating the Field Corrective Action notices by hand delivery on 10/02/2018 and followed with the posting of Medtronic Security Bulletin and the Urgent Medical Device Correction customer letter online on 10/11/2018.
The notice explained 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 and beginning October 11th, 2018, Medtronic will be disabling the SDN for programmer updates and will rely solely on the USB update method. |
Quantity in Commerce |
30172 units |
Distribution |
Worldwide |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
PMA Database |
PMAs with Product Code = OSR and Original Applicant = Medtronic, Inc.
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