| Date Initiated by Firm | July 29, 2025 |
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| Date Posted | August 29, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2433-2025 |
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| Recall Event ID |
97363 |
| Product Classification |
Catheter, percutaneous - Product Code DQY
|
| Product | 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. |
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| Code Information |
GTIN 08714729965725, ALL NON-EXPIRED BATCHES |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
|
| For Additional Information Contact | Clara Johnson
763-494-1133 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Quantity in Commerce | 340185 units in total |
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| Distribution | Worldwide. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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