ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
FDA Recall Z-0870-2021 · Posted None
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2020-12-15
Date Terminated2023-08-14
Product Quantity5 units
Reason for Recall
Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.
Firm Action
The firm initiated the recall by hand delivered letter. The letter explained the issue and requested the following actions be taken:
"1. Immediately segregate all affected product to ensure that it will not be used.
2. Your local Boston Scientific sales representative will retrieve affected product.
3. Complete the enclosed Reply Verification Tracking Form.
4. If affected product has been used, please inform the implanting physician for appropriate patient management."
"If you have further questions, please contact your local Boston Scientific representative or United States Technical Services at 1-800-227-3422."
Root Cause
Process control
Distribution Pattern
US Nationwide distribution including in the states of Tulsa, OK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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