A laser surface preparation may not have properly prepared the device’s metal housing potentially leading to abnormal device-to-header adhesion which may allow moisture ingress into the header.
ANZCDACC Product Hazard Alert July 2022
Device: A subset of Assurity™, Endurity™ and Zenex™ Pacemakers
MODELS: PM2162, PM2172, PM2272, PM2282*
* TGA Approved but not currently commercially released
TGA Reference:
RC-2022-RN-01000-1