September 29, 2025 – Boston Scientific notified customers of the possibility of air embolism with use of the WATCHMAN access sheaths and has updated their IFU along with physician training.
Authors
Molly Sachdev, MD, MPH; Mina Chung, MD; Sana Al-Khatib, MD; Christopher F. Liu, MD; Lisa Miller, MS; Anne Marie Smith, MBA; Amit J. Shanker, MD
Correspondence
[email protected]
Impacted Models
All versions of WATCHMAN Access Sheath Systems currently available worldwide.
Recall Issue Summary
Boston Scientific has notified customers of the possibility of air embolism with use of the WATCHMAN access sheaths and has updated their IFU along with physician training.
Based on a U.S. registry, this risk appears to be approximately three-times higher in patients when conscious or deep sedation is used as opposed to positive pressure controlled ventilation1. The risk is specifically prevalent in patients with low left atrial pressure, hypovolemia, and partial upper airway collapse. Negative left atrial pressures may increase the risk of air ingress through the hemostatic valve, particularly when the valve is open during device exchanges.
Air embolism can lead to severe outcomes including arrythmias, hemodynamic collapse, stroke, or other end-organ failure caused by ischemia. As of initial reporting, the global rate of air embolism under any sedation type was 0.06%, associated with death in 0.009% of cases. At that time, 120 serious injuries and 17 deaths had been reported in association with this issue.
1 Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750
Manufacturer Recommendations
Boston Scientific is recommending:
- Ensure the patient is not hypovolemic prior to the procedure
- Hold the WATCHMAN access sheath valve below the heart level and/or under fluid during insertion to reduce the likelihood of air ingress.
- Minimize a vacuum effect by withdrawing devices slowly until near the valve, then making exchanges during expiration.
The risk of air embolism is limited to the duration of the procedure only. Patients who have already undergone Watchman implant do not require any additional precautions beyond current standards.
HRS Recommendations
HRS strongly encourages its members to review the Advisory with the updated instructions for use related to air embolism to ensure good sheath management to minimize the risk of air embolism. These updates will be added to the WATCHMAN Access Systems IFUs and WATCHMAN Physician Training.
For reference, the U.S. FDA’s Early Alert is available here, and the Class I Recall is available here.
Reporting Contact
Adverse events should be reported to your local Boston Scientific representative or Technical Services and to regulatory authorities such as the FDA for our US based members.
FDA’s MedWatch
Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
If further support is required, contact Boston Scientific Technical Services at [email protected].
Topic
- Device Therapy
- Electrophysiology
Manufacturer
- Boston Scientific
Device Type
- LAAC Device
FDA Class
- Class I
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