Moisture Entry Can Cause Short Circuit in Abbott Pacemakers
Abbott – formerly known as St. Jude Medical – is recalling a subset of its Assurity and Endurity implantable pacemakers in response to reports of the devices short circuiting. According to the FDA announcement, moisture has been found to enter a number of Assurity and Endurity pacemakers distributed between April 2015 and February 2019. The moisture can cause an electrical short, which could lead to an unexpected and rapid decrease in battery life, errors in data delivery, and even a loss of device pacing. Patients who lose the pacing the devices are intended to provide may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness, and discomfort. Unfortunately, Abbott is already aware of 135 injuries and complaints linked to these pacemakers.
The recalled devices are known as Scalable Bradycardia Platform (SBP) Pacemakers. SBP Pacemakers are implanted under the chests of patients suffering from slow heartbeat (“bradycardia”). The implanted devices are intended to monitor the heart’s activity and provide pacing for slow heartbeats. Unfortunately, the devices have been found to present an increased risk of short circuiting. The pacemakers short circuiting can lead to severe injury or even death. Accordingly, the FDA has labeled this a Class I recall, its most serious designation.
Based on current reporting, the recall affects 61,973 Abbott Pacemakers built using specific manufacturing equipment. The devices that could be affected by this malfunction were distributed between April 2015 and February 2019.
If you or a loved one suffered injuries you suspect were caused by the Assurity or Endurity Pacemakers, contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers have a proven history of results for thousands of clients nationwide. They possess the knowledge, resources, and skill needed to get you the justice and compensation you deserve. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.