Device recall: WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and…
Class I FDA enforcement event 97363. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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…
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Boston Scientific Corporation started this device recall on 29 Jul 2025. The firm address in the FDA record is in Maple Grove, MN. FDA put the recall in Class I. FDA event 97363 has 11 product records. The first FDA enforcement report date is 10 Sep 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide.
Recalling firm
Boston Scientific Corporation, Maple Grove, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2426-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2427-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2428-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2429-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2430-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2431-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2432-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2433-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2434-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2435-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
| Z-2436-2025 | 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. | 340185 units in total | Class I | Ongoing | 10 Sep 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class I
- 13%
- Product records in this event
- 11Median of the firm: 2
- Events of the firm on the register
- 162
Other events of the firm
Official channels
- FDA enforcement report Z-2426-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 97363. https://recallregister.com/fda/i/97363/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide.
- What quantity of product is in FDA event 97363?
- The event has 11 product records. The first record gives this quantity:
340185 units in total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 13% of the 945 device events that started in 2025 are in Class I.