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Acurate neo2 and acurate prime
Official notice
2 Dec 2024
Last checked
2 Dec 2024
An official Health Canada notice concerns Acurate neo2 and acurate prime. Boston Scientific has become aware of new information related to valve underexpansion, that emerged from review of the 1-year clinical trial data from the ACURATE IDE. Detailed investigation of the 1-year data identified valve underexpansion as a potential leading contributing factor of the missed primary endpoint (ACURATE neo2 non- inferiority to the Control group for the composite of death, stroke and rehospitalisation). ACURATE neo2 valve underexpansion was associated with an increased rate of primary endpoint events compared to cases where the ACURATE neo2 valve was well expanded. However, valve underexpansion was not previously identified through clinical experiences with the ACURATE neo2 valve nor through ACURATE neo2 post market surveillance. The Instructions for Use (IFU) have been updated to include the risk of valve underexpansion and the practices that may reduce this risk. Recall start date: November 7, 2024 Published 2024-12-02.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76521
Official notice
2024-12-02
The hazard
The hazard
Boston Scientific has become aware of new information related to valve underexpansion, that emerged from review of the 1-year clinical trial data from the ACURATE IDE. Detailed investigation of the 1-year data identified valve underexpansion as a potential leading contributing factor of the missed primary endpoint (ACURATE neo2 non- inferiority to the Control group for the composite of death, stroke and rehospitalisation). ACURATE neo2 valve underexpansion was associated with an increased rate of primary endpoint events compared to cases where the ACURATE neo2 valve was well expanded. However, valve underexpansion was not previously identified through clinical experiences with the ACURATE neo2 valve nor through ACURATE neo2 post market surveillance. The Instructions for Use (IFU) have been updated to include the risk of valve underexpansion and the practices that may reduce this risk. Recall start date: November 7, 2024
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Affected area 1
Company & contacts
Company & contacts
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Phone
Brand: Boston Scientific, Acurate Neo2 And Acurate Prime.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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