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U.S. Department of Health and Human Services

Class 2 Device Recall ACUITY Universal Cutter

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 Class 2 Device Recall ACUITY Universal Cuttersee related information
Date Initiated by FirmDecember 15, 2020
Create DateJanuary 15, 2021
Recall Status1 Terminated 3 on August 14, 2023
Recall NumberZ-0870-2021
Recall Event ID 87033
510(K)NumberK080154 
Product Classification Catheter, percutaneous - Product Code DQY
ProductACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
Code Information GTIN 08714729936176, Lot Number H1937249
FEI Number 2124215
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N Bldg 3
Saint Paul MN 55112-5700
For Additional Information ContactUnited States Technical Services
800-227-3422
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionThe 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."
Quantity in Commerce5 units
DistributionUS Nationwide distribution including in the states of Tulsa, OK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = DQY
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