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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05
Recalled May 12, 2021 · FDA recall Z-1523-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
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). · FDA Class II
Units
45,411 devices
Sold at
Worldwide
Description
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).
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)
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →