Boston Scientific Corporation ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
GTIN 08714729936176, Lot Number H1937249
Products Sold
GTIN 08714729936176, Lot Number H1937249
Boston Scientific Corporation is recalling ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal a due to Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing proc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026