FDA Medical Device Recalls (openFDA)
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 number
- Z-0870-2021
- Recalling firm
- Boston Scientific Corporation
- Product
- ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
- Status
- Terminated
- Initiated
- 2020-12-15
- Posted
- not on file
- Terminated
- 2023-08-14
- Reason
- 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
- Process control
- 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."
- Quantity
- 5 units
- Distribution
- US Nationwide distribution including in the states of Tulsa, OK.
- Lot, serial or model codes
- GTIN 08714729936176, Lot Number H1937249
- 510(k) numbers
- ["K080154"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28