Recall Z-0870-2021— Boston Scientific Corporation

Name: FDA recall Z-0870-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-15

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-12-15, terminated 2023-08-14. It names one FDA 510(k) clearance: K080154. Product: ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.. Reason: Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-12-15
Terminated: 2023-08-14
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K080154 — ACUITY UNIVERSAL CUTTERCardiac Pacemakers, Inc.·cleared 2008-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.