CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
- Recall Initiated
- April 6, 2021
- Recall Number
- Z-1522-2021
- Quantity
- 16,311 devices
- Firm Location
- Mounds View, MN
Reason for Recall
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
Distribution
Worldwide
Lot / Code Info
All serial numbers
Root Cause
Software design
Action Taken
Beginning 06-APR-2021, Medtronic notified risk managers and practice managers of the field corrective action notification via 2-day UPS delivery of the consignee letter. Confirmation delivery of the consignee letter will be obtained. Medtronic Field Representatives have been instructed to begin installation of the software update. Outside the United States (OUS), communication began on 06- APR-2021 using locally approved methods. Medtronic Field Representatives will begin installation of the software update as it is available locally. Consignees were advised that Medtronic representatives can assist in installing the software update on programmers. During device interrogation with an updated programmer at implant or the next regularly scheduled clinic visit, a patients device will automatically receive the updated software. A courtesy notification will be provided to physicians. No confirmation will be required for the courtesy notification.