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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00815-1
Product Name/Description	WATCHMAN Left Atrial Appendage Closure Device with Delivery System Material Numbers: M635WC21060, M635WC24060, M635WC27060, M635WC30060, M635WC33060, M635WS21060, M635WS24060, M635WS27060, M635WS30060, M635WS33060, M635WU21060, M635WU24060, M635WU27060, M635WU30060, M635WU33060 WATCHMAN Access System Access Sheath with Dilator Material Numbers: M635TC10060, M635TC20060, M635TS10060, M635TS20060, M635TS40060, M635TU10060, M635TU20060, M635TU40060 ARTG Numbers: 216434 and 216435
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	27/08/2015
Responsible Entity	Boston Scientific Pty Ltd
Reason/Issue	BSC has identified that cross-threading of the haemostasis valve may occur if the valve is tightened with the dilator in place, potentially preventing subsequent sealing of the valve when desired. This product correction reinforces existing Directions for Use (DFU) and provides further guidance regarding the correct use of the haemostasis valve in order to avoid cross-threading and to securely seal the valve, minimising the potential for undesirable blood leakage during surgery.
Recall Action	Recall for Product Correction
Recall Action Instructions	Boston Scientific is providing implanting surgeons with additional instruction to ensure that the risk of cross-threading of the haemostasis valve is mitigated. The product instruction for use are also being updated with this information.
Contact Information	02 8063 8100 - Boston Scientific