No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
No image published for this recall
Acurate neo2 and acurate prime
Official notice
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 product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
Checked manually this time?
The app alerts you when a new official recall is published — no searching, no checking back.
Turn on recall alertsAffected products
Affected products
Product 1
Product 2
Product 3
Product 4
Product 5
Product 6
Product 7
Product 8
Product 9
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Boston Scientific, Acurate Neo2 And Acurate Prime.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
View full official noticeRelated recalls
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Faradrive™ steerable sheath
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Icefx™ cryoablation console
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Accolade™ and visionist™ crt-p pacemakers
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Encore™ 26 inflation device, encore™ 26 advantage kits, nephromax™ kits and uromax ultra™ kits
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Watchman™ access systems
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Reliance defibrillation leads
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Carotid wallstent™ monorail
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Avvigo™+ multi-modality guidance system
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Polarx fit short and long tip cryoablation balloon catheter
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Accolade™ mri pacemaker
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Expo angiographic catheters
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Isleeve™ expandable introducer set
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Faradrive™ steerable sheath
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Icefx™ cryoablation console
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Accolade™ and visionist™ crt-p pacemakers
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Encore™ 26 inflation device, encore™ 26 advantage kits, nephromax™ kits and uromax ultra™ kits
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Watchman™ access systems
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Reliance defibrillation leads
Brand match
Critical risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Carotid wallstent™ monorail
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Avvigo™+ multi-modality guidance system
Brand match
Medium risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Polarx fit short and long tip cryoablation balloon catheter
Brand match
High risk
Markets
No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
Accolade™ mri pacemaker
Brand match
High risk
Markets
Weekly recall digest
Get next week's recalls before you need them.
One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.
The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.
This recall was published 2 Dec 2024. The next one won't wait for you to search.
RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.
