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 Boston Scientific is correcting and alerting users about ACCOLADE and VISIONIST pacemakers due to an unspecified issue. This recall affects single and dual chamber ACCOLADE pacemakers in standard and extended life models, as well as VISIONIST cardiac resynchronization therapy pacemakers distributed throughout Australia. The recall is classified as Class I, indicating a serious issue.
- Reason
- Boston Scientific is conducting a Product correction and Product alert for ACCOLADE and VISIONIST pacemakers.
- Classification
- Class I
- Category
- medical device recall
- Country
- Australia
- Agency
- Therapeutic Goods Administration
- Recall date
- 2026-04-01
- Status
- Ongoing
- Distribution
- Australia-wide
Official recall notice from Therapeutic Goods Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/91359865-8092-4036-a729-babe24f895d4