ACUITY Universal Cutter, MODEL 7060 - Product Usage:… recallZ-0870-2021 · Boston Scientific Corporation · initiated Dec 15, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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."
Recall details
- Recall number
- Z-0870-2021
- Status
- Terminated
- Initiated by the company
- Dec 15, 2020
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 5 units
- Product code
- DQY
- FDA submissions
- K080154
- Distribution
- US Nationwide distribution including in the states of Tulsa, OK.
Product description
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
Code information (models, lots, serial numbers)
GTIN 08714729936176, Lot Number H1937249
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACUITY™ 7060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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