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