FDA Device recall Z-2428-2025

WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040

• FDA Device
• Class I
• ongoing
• Published 2025-09-10

On 2025-09-10 the FDA classified a Class I recall of WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040 by Boston Scientific, citing boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published….

Read the official FDA Device notice

Product

WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2428-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.