WATCHMAN TruSeal Access System (Boston Scientific) – air embolism (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
GTIN 08714729965732, ALL NON-EXPIRED BATCHES
Products Sold
GTIN 08714729965732, ALL NON-EXPIRED BATCHES
Boston Scientific Corporation is recalling WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vasc due to Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventila. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 (U.S. study) 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.
Recommended Action
Per FDA guidance
Boston Scientific issued an Important Medical Device Advisory notice to its consignees on 07/29/2025 via FedEx. The notice explained the problem with the device, procedures under which the likelihood of the problem occurs, and risk to the patient. The WATCHMAN Access Systems Instructions for Use (IFUs) and WATCHMAN physician training will be updated to emphasize instructions related to Access System air management. This update will strengthen the information provided to clinicians regarding the potential for air embolism during WATCHMAN procedures performed under conscious or deep sedation and provide potential mitigation strategies. No devices are being removed. Instructions: 1. Review IFU updates related to air embolism as detailed in Appendix 2. These updates will be added to the WATCHMAN Access Systems IFUs and WATCHMAN Physician Training. 2. 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. 3. Complete and return the enclosed Acknowledgment Form. If additional assistance is required or more information regarding this communication, customer should contact your local Boston Scientific representative or Sr. Quality Systems Manager at 763-494-1133.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026