Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19083 |
| Brand Name: | Boston Scientific Watchman Left Atrial Appendage Closure Device with Delivery System |
| Model: | All models |
| Affected: | Selected lots |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Brand Name: | Boston Scientific Watchman Access System Access Sheath with Dilator |
| Model: | All models |
| Affected: | Selected lots |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Issue: | The manufacturer has determined cross-threading of the hemostasis valve may occur if the valve is tightened with the dilator in place, potentially preventing subsequent sealing of the valve when desired. The manufacturer has issued a recall for product correction to reinforce existing Directions for Use (DFU) and provide further guidance regarding the correct use of the hemostasis valve in order to avoid cross-threading and to securely seal the valve, minimizing the potential for undesirable blood leakage. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/9/2015 |
