Recall Z-2427-2025 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
| Date | Aug 29, 2025 (initiated Jul 29, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 340185 units in total |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180864 | WATCHMAN TruSeal Access System Boston Scientific, Jul 20, 2018 |