The January recall of 48 Medtronic CRT-D and ICDs has now been expanded to include 752 additional devices at lower risk than those involved in the January recall,. There is an issue that occurred during the manufacturing process of these devices which could result in an unexpected loss of device functionality. If you have one of these devices, you should contact your doctor to discuss next steps.
You can see the advisory here.
To look up your device by product name, model or serial number to see whether it is impacted, click here.
The box in the upper right corner labeled “Advisories For This Model” will tell you if there are any advisories for your device.
If you are affected, the search page would look like this:
This example shows that currently there are no advisories for my model.
As always, you can call Medtronic Patient Services with any questions at: (800) 551-5544 (M – F, 8am – 5pm Central)
Medtronic has recalled a small number of ICDs and CRT-D devices. A total of 48 devices implanted in patients may contain a manufacturing defect which would prevent the device from delivering an appropriate shock if needed.
This is a Class I recall, which is the most serious as determined by the FDA.
Physicians of record of those affected by the recall should have already been notified by Medtronic.
You can also contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time).
St. Jude Medical announced today that as many as 400,000 of its Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured prior to May 23, 2015 are subject to a recall notice due to a risk of premature battery depletion which may render the device unable to deliver a life saving shock.
According to the FDA, the patients most at risk are those who require lifesaving shocks and those who are pacemaker dependent.
The problem has so far resulted in two deaths.
Patients with these devices should contact their physicians for advice about how to proceed, and should seek immediate medical attention if they hear a low-battery alert from their Merlin monitoring device. Continue reading “St. Jude Medical ICD Recall”