FDA – A news report posted on cardiovascularbusiness.com states that the U.S. food and drug administration has announced the recall of more than 60,000 Abbott Assurity and Endurity implantable pacemakers. According to the FDA recall notice, the implantable pacemakers affected by the recall pose a risk of electrical shorts that could lead to significant complications or even death.
The FDA has classified the recall as a class one recall, which means the recalled Abbott Assurity and Endurity implantable pacemakers May cause serious injury or death. The FDA has received reports of 135 injuries related to the implantable pacemaker defect. However, no deaths have been reported at this time.
The recall notice states that the issue pertains to moisture buildup that may cause the Assurity or Endurity implantable pacemakers to Malfunction, causing the device to have battery issues, lose its pacing, create telemetry problems, and have other potential problems.
According to a statement from the FDA, “if the device is unable to deliver patient, the patient may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness, or discomfort. The FDA also stated that the device defect might shorten the life of the battery, and the medical device could lead to the pacemaker needing to be replaced sooner than expected. Another essential problem is the devices in the ability to relay accurate information via its telemetry system. This issue will make it difficult for medical providers to determine and provide proper treatment.
The Abbott Assurity and Endurity implantable pacemakers that have been affected by the recall were all distributed from April 29, 2015, two February 20, 2019. The news report states that Abbott has informed affected customers on March 2021. The report states that the notice claims that the medical device is not required to be replaced at this time if there is no “evidence of the issue. “Treating physicians are also urged to “remind patients of the importance of using remote monitoring. ”
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