Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): 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).

Agency Publication Date: April 30, 2021

Affected Products

Product: CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

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Product: CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT)

all serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87654

Status: Active

Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Manufactured In: United States

Units Affected: 2 products (16,311 devices; 45,411 devices)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

All serial numbers

all serial numbers