Print version of this report

TGA Action ID	RC-2026-RN-00707-1
Type of Product	Medical Device
Product Name/Description	Direxion and Direxion HIFLO Microcatheters Multiple descriptions and batch numbers Expiration date range: 23 October 2027 to 28 July 2028
ARTG Number	275748
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	A manufacturing problem may cause difficulty withdrawing the device from the carrier hoop and difficulty advancing or withdrawing the device through a guide catheter. The problem is detectable during device preparation and/or use in the patient and is experienced as increased resistance between the microcatheter and other components. This increased resistance, including attempts to advance or withdraw the device when resistance is encountered, may result in damage to the microcatheter. Potential adverse health consequences include prolonged procedure, vessel trauma, vasospasm, additional intervention to retrieve a separated device fragment, unretrieved device fragment, thrombosis, or embolism. Boston Scientific has received an increased number of complaints associated with increased resistance and resistance-related damage, representing a complaint rate of 0.352%. Most reported outcomes involved device exchange/procedure delay without patient injury. The most serious observed outcome was a single reported event of shaft separation within the body requiring an additional intervention to retrieve the retained fragment. This was the only serious injury reported.
Instructions for Customers/Users	Customers are to: - Immediately stop further use or distribution and quarantine affected product. - Continue to follow the standard of practice when monitoring patients that have been treated with the product. - Return product to Boston Scientific. Credit will be issued for all returned affected product.
Action Commencement Date	17/09/2026
Responsible Entity	Boston Scientific Pty Ltd
Contact Information	ANZ_Incident_Report@bsci.com - Boston Scientific