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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00772-1
Product Name/Description	Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels) Item Numbers: 542102, 542103, 542152, 542153, 542154, 543101, 543102, 543103, 543151, 543152, 543153, 543154, 544203, 544204, 544254, 544304, 544306, 544356, 545202, 545203, 545204, 545206, 545253, 545254, 545256, 545304, 545306, 545308 Multiple lot numbers affected ARTG Number: 170214
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	9/06/2016
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker Neurovascular has become aware that some units of the Target Nano Detachable coils do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching. The most likely adverse health consequence from coil stretching is prolongation of the procedure, as the stretched coil needs to be removed from the patient and replaced. There is a potential of thrombus formation when the stretched coil is left exposed in the blood flow. Additional intervention may be required to snare the stretched coil or pin it to the vessel wall with a stent if safe removal is not possible. This may result in thrombus or thromboembolism which can lead to stroke. There will be no long term adverse health consequence after a stretched coil is removed from the body.
Recall Action	Recall
Recall Action Instructions	Stryker is advising users to inspect stock and quarantine any remaining affected units for return. This action has been closed-out on 03/03/2017.
Contact Information	02 9467 1175 - Stryker