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TGA Action ID	RC-2026-RN-00712-1
Type of Product	Medical Device
Product Name/Description	OmniaSecure MRI SureScan Defibrillation Leads Model: 3930M Serial Numbers: CDD408717V, CDD408718V, CDD408720V, CDD408841V, CDD408842V, CDD408851V, CDD408877V, CDD408878V, CDD408880V, CDD411184V, CDD411185V, CDD411304V, CDD411306V, CDD411322V, CDD411323V, CDD411331V
ARTG Number	524898
Unique Device Identifier (UDI)	00763000759919
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Medtronic identified a subset of OmniaSecure defibrillation leads which may have undergone a specific manufacturing sequence that requires the leads to be retrieved for additional engineering evaluation. The potential harm is tissue trauma due to implant difficulty. As of 27 August 2026, Medtronic has received five complaints associated with this problem. In each complaint, difficulty achieving fixation was reported during the implant procedure; none of the leads were implanted. There have been zero reports of patient harm.
Instructions for Customers/Users	Customers are to: • Identify and quarantine affected non-implanted leads. • Return the non-implanted leads to Medtronic. A Medtronic field representative will assist with a replacement solution. Medtronic will provide additional information to customers, if appropriate, based on the ongoing engineering evaluation. If one of the identified lead(s) is implanted, there is no further action required beyond current standard of care.
Action Commencement Date	17/09/2026
Responsible Entity	Medtronic Australasia Pty Ltd
Contact Information	02 9857 9000 - Medtronic