Boston Scientific Watchman and Defibrillation Devices Linked to Hundreds of Injuries, Dozens of Deaths

Warnings have been issued for two Boston Scientific heart devices due to potential malfunctions and risks that may result in life-threatening injuries.

Two safety warnings have been issued for Boston Scientific’s Watchman Access System and defibrillation lead coils, citing risks of severe complications, including stroke, organ failure and sudden cardiac death.

The Watchman Access System includes tools used by physicians to implant the Watchman FLX device, which helps reduce the risk of stroke in patients with atrial fibrillation by sealing off the heart’s left atrial appendage, where dangerous clots often form. However, if the access system malfunctions during the procedure, it can lead to serious medical emergencies such as air embolisms, arrhythmias or circulatory collapse.

Defibrillation leads are insulated wires designed to monitor heart rhythms and deliver electrical pulses or shocks through an implanted defibrillator. If these leads fail, especially during a cardiac event, they may be unable to deliver lifesaving therapy, increasing the risk of sudden cardiac arrest or other life-threatening outcomes.

Federal officials report that more than 500 serious injuries and at least 33 deaths have been associated with the two Boston Scientific devices under investigation.

Watchman Access System Early Alert

The Boston Scientific Watchman Access System warning was announced by the U.S. Food and Drug Administration (FDA) on August 6, cautioning that improper ventilation during the device’s implant procedure may increase the risk of air embolism, which can lead to serious complications.

Officials warn that if patients are not given positive pressure controlled ventilation during the device’s insertion, an air embolism could occur in the heart, leading to serious and potentially deadly problems like irregular heartbeats, collapse of blood circulation, stroke or organ failure.

The risk of air embolism is acute and limited to the implant procedure. Patients with a previously implanted Watchman device need no special management and should follow standard care as directed by their physician.

The affected devices include all lots of certain Watchman TruSeal, FXD Curve and TruSteer Access Systems with specific Unique Device Identifier (UDI) numbers listed in the warning notice.

Boston Scientific is aware of at least 120 serious injuries and 17 deaths associated with this issue.

A letter was sent to all affected customers on July 30, advising users to review the following Instructions for Use updates:

• Physicians are being warned that sedated patients have a higher risk of air bubbles entering the heart, which can be extremely dangerous. This risk can be lowered by using a breathing machine that gently pushes air into the lungs, known as positive pressure ventilation.
• To help prevent this problem, doctors should make sure patients are not dehydrated or have low blood volume, especially if they are not using a breathing machine that helps regulate pressure.
• When inserting the Watchman heart device, the tube, or sheath, should be kept below heart level or submerged in fluid to stop air from getting inside. To avoid creating suction, tools should be removed slowly and device changes should be timed with the patient’s exhale.

Boston Scientific says the warning letter is meant to be shared with all clinicians performing Watchman procedures and with facilities receiving affected devices. Distributors should forward this notice to their customers. 

Consumers are advised to check the FDA’s webpage for updates as the agency continues to review this potentially high-risk device issue. Customers with questions can contact Boston Scientific at ICardioQAComplaints@bsci.com.

Boston Scientific Defibrillation Lead Early Alert

The FDA announced the Boston Scientific defibrillation lead warning on August 6 as well, cautioning that the coil in certain defibrillation leads may calcify, reducing shock energy.

The alert was issued after Boston Scientific discovered that calcium buildup on wires in some of its heart devices can interfere with the delivery of electrical shocks. Over time, this buildup may prevent the device from stopping dangerous heart rhythms effectively.

While early lead replacement is the most common outcome, failed shock delivery can lead to emergency resuscitation or even death. Boston Scientific has reported 386 serious injuries and 16 patient deaths linked to the issue.

The warning applies to certain Boston Scientific Endotak Reliance, Reliance 4-Site and Reliance 4-Front defibrillation leads with expanded polytetrafluoroethylene (ePTFE)-coated coils. Specific model numbers are listed in the FDA warning letter.

Boston Scientific sent a letter to all affected healthcare providers on July 24, advising them to continue routine follow-ups of defibrillation systems, and check how easily or strongly electrical signals flow through the heart device during small and strong shocks. If wires need replacing, risks of removing versus leaving in place must be weighed, as hard calcium buildup on the coil could make removal more dangerous.

The warning letter should be shared with all relevant healthcare professionals in the organization. Consumers are advised to check the FDA’s webpage for updates as the agency continues to review this potentially high-risk device issue.

Customers with questions can contact Boston Scientific at 1-800-227-3422 or via email at tech.services@bsci.com.