Recall Z-0230-2023— Boston Scientific Neuromodulation Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Neuromodulation Corporation, initiated 2022-10-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm. Reason: 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..
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-12
- Firm location
- Valencia, CA, United States
Product description
Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.