CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Reported: May 12, 2021 Initiated: April 6, 2021 #Z-1522-2021
Product Description
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
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).
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 16,311 devices
- Distribution
- Worldwide
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 16,311 devices.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 12, 2021. Severity: Moderate. Recall number: Z-1522-2021.
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