Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-2432-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

Product Classification:

Class I

Date Initiated: July 29, 2025

Date Posted: September 10, 2025

Recall Number: Z-2432-2025

Event ID: 97363

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.

Status: Ongoing

Product Quantity: 340185 units in total

Code Information:

GTIN 08714729965718, ALL NON-EXPIRED BATCHES

Distribution Pattern:

Worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated