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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic CareLink Encore 29901 Programmer

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 Class 2 Device Recall Medtronic CareLink Encore 29901 Programmersee related information
Date Initiated by FirmOctober 02, 2018
Create DateNovember 08, 2018
Recall Status1 Open3, Classified
Recall NumberZ-0407-2019
Recall Event ID 81300
PMA NumberP890003S398 
Product Classification Pacemaker/icd/crt non-implanted components - Product Code OSR
ProductMedtronic CareLink Encore 29901 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 ContactMedtronic 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
ActionThe 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 Commerce4072 units
DistributionWorldwide
Total Product Life CycleTPLC Device Report
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 DatabasePMAs with Product Code = OSR
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