ACCOLADE single chamber (SR), dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps)
AustraliaACCOLADE single chamber (SR), dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps)
Recalling Firm: TGA
Reason for Recall / Hazard
Boston Scientific is conducting a Product correction and Product alert for ACCOLADE and VISIONIST pacemakers....
Product Description & Identification
Boston Scientific is conducting a Product correction and Product alert for ACCOLADE and VISIONIST pacemakers.
Affected Products
ACCOLADE single chamber (SR), dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | https://www.tga.gov.au/node/556070 |
| Guid › @ is Perma Link | true |
| Link | https://www.tga.gov.au/safety/recalls-and-other-market-actions/market-actions/accolade-single-chamber-sr-dual-chamber-dr-standard-life-sl-and-dr-extended-life-el-pacemakers-and-visionist-cardiac-resynchronization-therapy-pacemakers-crt-ps-0 |
| Pub Date | Wed, 01 Apr 2026 00:00:00 +1100 |
| Extracted category | devices |
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Overview
- Recalling FirmTGA
- Risk LevelMedical Device Correction
- DistributionAustralia
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🚨 SAFETY ALERT: TGA - ACCOLADE single chamber (SR), dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps) Check if your household is affected: https://therecallfile.com/recalls/accolade-single-chamber-sr-dual-chamber-dr-standard-life-sl-and-dr-ext/AU-TGA-556070
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