Medtronic has been alerting doctors about software updates for thousands of implantable heart devices worldwide that can experience unexpected problems.On Tuesday, the Food and Drug Administration publicized alerts that Medtronic voluntarily sent out in late June regarding 25,000 EnTrust and Escudo implantable cardioverter defibrillators (ICDs) and 14,000 Percepta and Percepta Quad cardiac resynchronization therapy pacemakers (CRT-Ps).”Medtronic has not received any reports of patient deaths or serious adverse events related to either issue,” Medtronic spokeswoman Tracy McNulty said via e-mail. The FDA designated both actions as Class 2 recalls, meaning there may be temporary or reversible adverse health consequences or the probability of adverse events is remote.Regarding EnTrust ICDs, Medtronic has confirmed incidents in which the older heart devices displayed warnings saying their batteries had lost the ability to deliver high-voltage therapy, even though they failed to show the early battery replacement warnings that are supposed to appear when the battery is just running low. The issue only affects high-voltage therapy, not low-voltage pacing.

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