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Recall Observatory FDA recall evidence

Device product

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

Z-0870-2021

December 15, 2020

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 87033
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-0870-2021

Official wording

Reason: Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.

Code information: GTIN 08714729936176, Lot Number H1937249

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.