ACURATE neo2 and ACURATE Prime recall in Canada: performance issue
In plain language
This recall involves ACURATE neo2 and ACURATE Prime medical devices sold in Canada. They are being recalled due to a performance issue related to valve underexpansion. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
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Affected products
ACURATE Prime Aortic Valve
Model: H74939690250 H74939690270 H74939690230 H74939690290
Lot: All lots.
ACURATE Neo2 Loading Kit
Model: SYM-AC-010
Lot: All lots.
ACURATE Prime Delivery System
Model: H749396822729 H749396822325
Lot: All lots.
ACURATE Neo2 Transfemoral Delivery System
Model: SYM-DS-005 SYM-DS-010
Lot: All lots.
ACURATE Prime Loading Kit
Model: H749396942729 H749396942325
Lot: All lots.
ACURATE Neo2 Valve
Model: SYM-SV27-004 SYM-SV23-004 SYM-SV25-004
Lot: All lots.
ACURATE Prime XL Delivery System
Model: SYM-DS-009-C
Lot: All lots.
ACURATE Prime XL Loading Kit
Model: SYM-AC-009-C
Lot: All lots.
ACURATE Prime XL Aortic Valve
Model: SYM-SV29-009-C
Lot: All lots.
Why this matters
Performance issue
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: H749396822729 H749396822325, H74939690250 H74939690270 H74939690230 H74939690290, H749396942729 H749396942325, SYM-AC-009-C, SYM-AC-010, SYM-DS-005 SYM-DS-010, SYM-DS-009-C, SYM-SV27-004 SYM-SV23-004 SYM-SV25-004, SYM-SV29-009-C
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue
What should consumers do?
Contact the manufacturer if you require additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue
When was this product recalled?
This product was recalled on December 2, 2024.
Is the BOSTON SCIENTIFIC CORPORATION brand affected by this recall?
Yes, BOSTON SCIENTIFIC CORPORATION products are affected by this recall. This recall involves ACURATE neo2 and ACURATE Prime medical devices sold in Canada. They are being recalled due to a performance issue related to valve underexpansion. Healthcare professionals should contact the manufacturer for more information.