Reported Jun 3, 2020 · Terminated
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to…
Boston Scientific Neuromodulation Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
- Fifty-five (55) cm 8 Contact Extension Kit, part
- number M365SC3138550 - Product UsageLead 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 ContentsLead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual
- Lot codes and dates
Part number M365SC3138550serial numbers 1044463106624230030601044464106858930066201044466106860230090411061554106860630090451062766106860830090501062770106861130101141062787300104630127811063430300254730132041063632300256130132671063650300281730181051063749300304030181061063798300304230188661063801300304730369731066182and 3003048
- Amount recalled
- 41 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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