Accolade Single Chamber (sr), Dual Chamber (dr) Standard Life (sl) And Dr Extended Life (el) Pacemakers; And Visionist Cardiac Resynchronization Therapy Pacemakers (crt-ps)
Recall Summary Certain ACCOLADE and VISIONIST pacemakers are being recalled due to a software issue that requires correction. The recall affects single chamber, dual chamber standard life, dual chamber extended life, and cardiac resynchronization therapy pacemaker models distributed across Australia. Healthcare professionals have been provided with specific actions to address the software correction.
- Reason
- Product correction and Product alert. This update includes new information regarding the software correction, actions for healthcare professionals and inclusion of the single chamber (SR) pacemaker.
- Classification
- Class I
- Category
- medical device recall
- Country
- Australia
- Agency
- Therapeutic Goods Administration
- Recall date
- 2025-09-11
- Status
- Ongoing
- Distribution
- Australia-wide
Official recall notice from Therapeutic Goods Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/aa7ec075-63df-4936-aac7-88b19b9207f8