FDA designates recall of two bradycardia pacemakers as Class I
The FDA has identified Abbott’s recall of two scalable bradycardia platform pacemakers as Class I, the most serious type of recall.
According to an FDA press release, there have been 135 injuries and no deaths reported for these devices (Assurity and Endurity, Abbott).
Abbott recalled pacemakers built using specific manufacturing equipment of which a small number have experienced problems when moisture is able to get inside the device. According to the release, this may cause:
- loss of device pacing;
- telemetry failure or errors in information;
- early and fast battery drain; and
- less time between the first battery depletion warning and the device’s end of service.
Consequences may include slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness, discomfort and earlier replacement than expected, according to the release.
According to a letter sent to customers by Abbott, the company does not recommend replacing the device if there is no evidence of the issue.
Read more about