Recall Z-2124-2020— Boston Scientific Neuromodulation Corporation

Class II FDA medical device recall by Boston Scientific Neuromodulation Corporation, initiated 2019-04-24, terminated 2022-01-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual. Reason: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue..

Recalling firm

Boston Scientific Neuromodulation Corporation

Classification

Class II

Status

Terminated

Initiated

2019-04-24

Terminated

2022-01-18

Firm location

Valencia, CA, United States

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