WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transsepta

FDA device recall Z-2434-2025 · posted 2025-08-29 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DQY

Quantity affected

340185 units in total

Distribution

Worldwide.

Date initiated

2025-07-29

Date posted

2025-08-29

Location

Maple Grove, MN

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