Over 61,000 Assurity and Endurity Pacemakers Recalled: Moisture Damage Caused Dozens Of Injuries
Abbott is recalling more than 61,000 St. Jude Assurity and Endurity pacemakers, following dozens of reports involving problems where moisture caused electrical shorts or disrupted the functions of the critical heart devices.
St. Jude Medical was acquired by Abbott in 2017, so the company is now responsible for scalable bradycardia platform (SBP) pacemakers sold under the Assurity and Endurity brands, which are used to detect when the heart is beating too slow and send signals to make it beat at the correct pace.
According to a recall notice posted by the FDA this week, more than 135 injury reports have been linked to Endurity and Assurity pacemakers after moisture was able to get inside the implantable devices. This can result in an electrical short which causes a loss of device pacing, telemetry failures, information errors and rapid battery failure.
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The implantable pacemakers are critical products, which are placed under the skin, with insulated wires that connect to the heart to keep the heart beating at an appropriate rhythm for one or more chambers of the heart.
Approximately 61,973 of the St. Jude pacemakers are being recalled, which were distributed to healthcare providers and medical facilities between April 29, 2015 through February 20, 2019.
Abbott issued a letter to customers on March 15, informing healthcare providers and patients of the potential defect along with instructions to schedule routine follow-ups with patients and to monitor the device functionality and replace pacemakers displaying elective replacement indicator or (ERI) or end of service (EOS) alerts.
Patients with implanted Assurity and Endurity pacemakers are being instructed to monitor for slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness, or discomfort, as these may be signs of the pacemaker experiencing moisture ingress.
Since the initial manufacturer letter, the FDA has classified the letter as a Class I recall, indicating it is the most serious of its kind and that the use of the product may cause serious adverse health consequences or death to consumers.
Customers with impacted devices are encouraged to contact Abbott Technical Support at 1-800-722-3774. The FDA is encouraging any and all adverse reactions or quality problems be reported to MedWatch, FDA Safety Information and Adverse Event Reporting Program.
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