Massive Medtronic Pacemaker Recall is Class I Says FDA
The Fridley, Minn.-based company issued a recall in January on pacemakers with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron due to a software error that can result in a lack of pacing.
Patients and physicians cannot predict whether and when this software error might occur, according to FDA, which gave the recall a Class I designation, the most serious type of recall. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light-headedness, fainting, and even death.
The company said two patient experienced a pause in pacemaking, but that no deaths were reported.
Medtronic said the root cause for the issue is related to a design change to an integrated circuit in a subset of devices that were distributed between March 10, 2017, and January 7, 2019. The recall includes 13,440 devices distributed in the U.S.
See Full Story at the Source: FDA gives massive Medtronic recall Class I designation – MassDevice
Written by: Nancy Crotti
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