FDA recall Z-0870-2021

Product

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-12-15

Report date

2021-01-27

Termination date

2023-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0870-2021