Recall Z-0796-2019 ยท OSR Pacemaker/Icd/Crt Non-Implanted Components
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
| Date | Jan 17, 2019 |
| Status | Terminated |
| Reason | The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values ba |
| Root cause | Software design |
| Action | In the US, beginning 17-Jan-2019, Medtronic Field Representatives hand delivered a courtesy FCA Notification Letter to consignees who, according to Medtronic records, have programmers that are eligible for Micra software updates. Field Representatives will update the identified programmers using a provided USB. Notification will also be hand delivered to Micra Implanting or Follow-up physicians for awareness of the issue. |
| Quantity | 33007 units |
| Distribution | US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.