Reported Nov 23, 2022 · Ongoing
Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
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?
- Superion¿ Indirect Decompression
- System (IDS) Model Numbers and Size101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
- Lot codes and dates
- Model (UPN)101-9808
- UDI-DI (GTIN) Code00884662000529
- Lot/Batch Numbers26176977
- Model (UPN)101-9812
- UDI-DI (GTIN) Code00884662000543
- Lot/Batch Numbers
2657343226375758268155602680766226654632269281682692960526489700
- Model (UPN)101-9814
- UDI-DI (GTIN) Code00884662000550
- Lot/Batch Numbers26366842 26848047 26619510 26323984 26406210 26799951
- Amount recalled
- 175 devices
Where it was sold
Why it was recalled
Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.
This product could cause temporary or reversible health problems — stop using it.
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