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Health technology company Abbott (formerly St. Jude Medical) has announced a Class I recall of 61,973 of its Assurity™ and Endurity™ pacemakers over moisture access that can cause an electrical short, posing risk of serious injuries or death.
Abbott initially announced the recall to customers on March 15, 2021, when it sent out a letter stating that a small number of pacemakers were manufactured with a defect that allowed water to enter the device, according to the U.S. Food & Drug Administration (FDA).
The recalled products were distributed from April 29, 2015 to Feb. 20, 2019 and includes Scalable Bradycardia Platform (SBP) Pacemakers: Assurity™ and Endurity™
To date there have been 135 complaints and 135 injuries reported regarding the pacemakers.
Abbott is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.
Assurity™ and Endurity™ are implantable pacemakers designed to detect excessively slow heartbeats, so they can send signals to the heart to make it beat at the right pace. The pacemakers can be used for either a singular chamber of the heart or both chambers, depending on the patient’s condition.
According to the recall notice, moisture entering the pacemaker can cause an electrical short that may result in the device stopping pacing, errors in information, battery failure or quick drainage, and a reduction in time between the first battery depletion warning (elective replacement indicator or ERI) and the device’s end of service (EOS).
If the device fails to deliver pacing, patients may experience “slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness, or discomfort,” the recall states. In addition, shorter battery life may require for the replacement of the pacemaker earlier than expected.
If the pacemaker does not relay accurate information, medical providers may not know to provide treatment, the recall states.
In the letter sent out by Abbott, patient management guidelines were provided with no recommendation for replacement if there were no signs of an issue with the device, and a routine follow-up protocol to evaluate risks for patients who rely on the pacemaker.
It also advised for a “prompt replacement for devices that reach ERI or EOS unexpectedly or experience a clinical impact.”
Consumers and healthcare professionals can also report any adverse reactions that have been had via the FDA’s MedWatch Adverse Event Reporting program .
Consumers who have further questions about the recall can contact Abbott Technical Support at 1-800-722-3774.
Do you or someone you know use a pacemaker? Let us know in the comment section below.
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3 thoughts onRecall Alert: Abbott Announces Recall of 61,973 Pacemakers, 135 Reportedly Injured
My husbands pacemaker is included in the recall but the manufacturer will not release any data or events transmitted from the pacemaker without the doctor’s authorization. That is my husband’s personal health information and does not belong to the doctor or the manufacturer. My husband is seeking his information which is being hidden from him. That is illegal.
Injury due to recalled pacemaker- never notified of recall
In October 2021, a Biventricular Allure Crtp Crm 2-S2983264 was implanted. In November of 2021, I received a notice from my doctor that there was a recall. I had surgery in December 2021. From 2015 to 2021, I have had many problems with the St. Jude pacemakers, leads, etc. I had heart surgery in 2015, they implanted a St. Jude pacemaker, and in three months I had to have it totally replaced in Boston. How can I enter a class action law suite?