Recall Z-0406-2019 ยท OSR Pacemaker/Icd/Crt Non-Implanted Components
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic CareLink 2090 Programmer
| Date | Oct 2, 2018 |
| Status | Open, Classified |
| 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. |
| Root cause | 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 | 30172 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.