—#185073

Product

ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K080154
Affected lot / code info: GTIN 08714729936176, Lot Number H1937249

Why it was recalled

Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.

Root cause (FDA determination)

Process control

Action the firm took

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."

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Bldg 3, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: US Nationwide distribution including in the states of Tulsa, OK.

Timeline

Recall initiated: 2020-12-15
Terminated: 2023-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185073. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.