CLASS I ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report
Watchman FXD Curve Access System Dbl, US, Material Number recalled
Boston Scientific is recalling Watchman FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020. The recall was initiated on 29 Jul 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2435-2025
- FDA event ID
- 97363
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 29 Jul 2025
- FDA classified
- 29 Aug 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 29 Jul 2025 | Recall initiated by company | |
| 29 Aug 2025 | Classified by FDA | +31 days |
| 10 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
GTIN 00191506013813, ALL NON-EXPIRED BATCHES
Where was it sold?
Worldwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 97363This product is part of a recall event; the main page for the event is Watchman TruSeal Access System SGL, US, Material Number recalled.
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