This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Boston Scientific has issued a letter to affected customers recommending all lots of certain WATCHMAN Access Systems have updated use instructions:

Material Description	Material	UDI-DI/GTIN
WATCHMAN TruSeal Access System SGL, OUS	M635TS70010	08714729965732
WATCHMAN TruSeal Access System DBL, OUS	M635TS70020	08714729965749
WATCHMAN TruSeal Access System ANT, OUS	M635TS70040	08714729965756
WATCHMAN FXD Curve Access Sys Dbl, OUS	M635TS80010	00191506013820
WATCHMAN FXD Curve Access Sys Dbl, US	M635TS80020	00191506013837
WATCHMAN TruSeal Access System SGL, US	M635TU70010	08714729965701
WATCHMAN TruSeal Access System DBL, US	M635TU70020	08714729965718
WATCHMAN TruSeal Access System ANT, US	M635TU70040	08714729965725
WATCHMAN FXD Curve Access Sys Sgl, US	M635TU80010	00191506013806
WATCHMAN FXD Curve Access Sys Dbl, US	M635TU80020	00191506013813
WATCHMAN TruSteer Access System, US	M635TU90050	00191506022310

What to Do

Review IFU updates related to air embolism and ensure notification of this medical device advisory to any clinicians who perform WATCHMAN procedures.

On July 30, Boston Scientific sent all affected customers a letter recommending the following actions:
- Review IFU updates related to air embolism as detailed below. These updates will be added to the WATCHMAN Access Systems IFUs and WATCHMAN Physician Training.
  - Warning: Patients under deep or conscious sedation are at increased risk for negative left atrial pressures, especially in the presence of hypovolemia or partial upper airway obstruction. Patients under controlled positive pressure ventilation such as general anesthesia have a reduced risk of negative atrial pressures. Negative left atrial pressures may increase the risk of air ingress through the hemostasis valve, particularly when the valve is open while introducing, removing or exchanging devices, which may result in air embolism. The most appropriate anesthesia method should be based on individual patient characteristics. Additional caution should be used with patients under deep or conscious sedation, such as:
    - Ensure the patient is not hypovolemic,
    - Make device exchanges with the access system valve below the level of the heart or under fluid, and withdraw devices slowly until near the valve, then make exchanges during expiration.
  - Precaution: Patients should not be hypovolemic, particularly if not under positive pressure ventilation, to reduce the likelihood of negative left atrial pressures and air embolism.
  - Precaution: Hold the WATCHMAN access sheath valve below heart level and/or under fluid during insertion to reduce the likelihood of air ingress. Vacuum can be minimized by withdrawing devices slowly until near the valve, then making exchanges during expiration.
- Forward this letter to any other clinicians in your medical facility who perform WATCHMAN procedures and to any facilities where affected devices have been transferred, including hospitals or sites within your network. If you are a distributor, this notice must be forwarded to your customers to ensure notification of this Medical Device Advisory is carried out to the end-user level.
- Complete and return the enclosed Acknowledgment Form.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.

During procedures performed without positive pressure ventilation, there is a known risk of air embolism leading to severe outcomes, including life-threatening or fatal consequences. These outcomes have been observed in this investigation and include arrhythmia, hemodynamic collapse, stroke (CVA), or other end-organ failure caused by ischemia.

The risk of air embolism is acute in nature and limited to the duration of the implant procedure. Patients who have a previously implanted WATCHMAN device do not require additional patient management and should continue to follow standard patient care at the discretion of their physician.

As of July 30, Boston Scientific has reported 120 serious injuries and 17 deaths associated with this issue.

Device Use

The WATCHMAN Access Systems are intended to provide vascular and transseptal access for the family of WATCHMAN FLX Left Atrial Appendage Closure Devices with Delivery Systems.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Boston Scientific at ICardioQAComplaints@bsci.com.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.