Z-2434-2025Class I

WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and...

Name: Z-2434-2025 WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and...
Creator: Boston Scientific Corporation
Published: 2025-07-29
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-07-29 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX... on 2025-07-29. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2434-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-07-29
Posted: 2025-08-29
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: DQY Catheter, Percutaneous
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.
FDA root cause: Under Investigation by firm
Action: Boston Scientific issued an Important Medical Device Advisory notice to its consignees on 07/29/2025 via FedEx. The notice explained the problem with the device, procedures under which the likelihood of the problem occurs, and risk to the patient. The WATCHMAN Access Systems Instructions for Use (IFUs) and WATCHMAN physician training will be updated to emphasize instructions related to Access System air management. This update will strengthen the information provided to clinicians regarding the potential for air embolism during WATCHMAN procedures performed under conscious or deep sedation and provide potential mitigation strategies. No devices are being removed. Instructions: 1. Review IFU updates related to air embolism as detailed in Appendix 2. These updates will be added to the WATCHMAN Access Systems IFUs and WATCHMAN Physician Training. 2. Forward this letter to any other clinicians in your medical facility who perform WATCHMAN procedures and to any facilities where affected devices have been transferred, including hospitals or sites within your network. If you are a distributor, this notice must be forwarded to your customers to ensure notification of this Medical Device Advisory is carried out to the end-user level. 3. Complete and return the enclosed Acknowledgment Form. If additional assistance is required or more information regarding this communication, customer should contact your local Boston Scientific representative or Sr. Quality Systems Manager at 763-494-1133.
Quantity in commerce: 340185 units in total
Distribution: Worldwide.
Product codes and lots: GTIN 00191506013806, ALL NON-EXPIRED BATCHES

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2434-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2426-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2427-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2428-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2429-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2430-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2431-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2432-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2433-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2434-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2435-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2436-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29

Product code DQY

K212228Class IIWATCHMAN FXD Curve Access SystemBoston Scientific Corporation / cleared 2021-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)