Z-0870-2021Class II

ACUITY Universal Cutter, MODEL 7060 -

Name: Z-0870-2021 ACUITY Universal Cutter, MODEL 7060 -
Creator: Boston Scientific Corporation
Published: 2020-12-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-12-15 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is... on 2020-12-15. FDA classified it as Class II and gives the reason as "Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0870-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-15
Posted: 2021-01-15
Terminated: 2023-08-14
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.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 5 units
Distribution: US Nationwide distribution including in the states of Tulsa, OK.
Product codes and lots: GTIN 08714729936176, Lot Number H1937249

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0870-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0870-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-15

Product code DQY

K080154Class IIAcuity Universal CutterCardiac Pacemakers, Inc. / cleared 2008-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)