Boston Scientific Corporation medical device recall: WATCHMAN TruSeal Access System SGL
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97363
- Recall initiated
- Jul 29, 2025
- Classified by FDA
- Aug 29, 2025
- Posted in Enforcement Report
- Sep 10, 2025
- Recalling firm
- Boston Scientific Corporation
- Firm location
- Maple Grove, MN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 11
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jul 29, 2025. FDA classified it 31 days later, on Aug 29, 2025. This recall event covers 11 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide. Boston Scientific Corporation has 169 recalls in our records.
Recalled products (11)
Z-2426-2025 Class I Ongoing
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Codes / lots: GTIN 08714729965732, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2427-2025 Class I Ongoing
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.
Codes / lots: GTIN 08714729965749, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2428-2025 Class I Ongoing
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.
Codes / lots: GTIN 08714729965756, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2429-2025 Class I Ongoing
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Codes / lots: GTIN 00191506013820, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2430-2025 Class I Ongoing
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Codes / lots: GTIN 00191506013837, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2431-2025 Class I Ongoing
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Codes / lots: GTIN 08714729965701, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2432-2025 Class I Ongoing
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.
Codes / lots: GTIN 08714729965718, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2433-2025 Class I Ongoing
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Codes / lots: GTIN 08714729965725, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2434-2025 Class I Ongoing
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Codes / lots: GTIN 00191506013806, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2435-2025 Class I Ongoing
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Codes / lots: GTIN 00191506013813, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Z-2436-2025 Class I Ongoing
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Codes / lots: GTIN 00191506022310, ALL NON-EXPIRED BATCHES
Quantity: 340185 units in total
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97363
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.