ACURATE neo2 and ACURATE Prime
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
ACURATE Prime Valve |
All lots. |
H74939690250 |
ACURATE Neo2 Loading Kit |
All lots. |
SYM-AC-010 |
ACURATE Prime Delivery System |
All lots. |
H749396822729 |
ACURATE Neo2 Transfemoral Delivery System |
All lots. |
SYM-DS-005 |
ACURATE Prime Loading Kit |
All lots. |
H749396942729 |
ACURATE Neo2 Valve |
All lots. |
SYM-SV27-004 |
Issue
Boston Scientific is initiating an advisory on important information regarding updates to the ACURATE neo2™ aortic valve system instructions for use (IFUs) and physician training related to the risk of valve under expansion. The updates related to the risk of valve under expansion are already included in the ACURATE Prime™ instructions for use (IFUs) and physician training.
Recall start date: November 7, 2024
Additional information
Details
| Boston Scientific Corporation |
| 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752 |
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