Boston Scientific Neuromodulation Corporation recalls Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion…
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver…
Read the official notice →- Date
- 2023-06-21
- Country
- United States
- Brand
- Boston Scientific Neuromodulation
- Product
- Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System…
- Classification
- Class II
- Units
- US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC,…Official notice → - 2024-06-05
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Boston Scientific Neuromodulation Corporation recalls Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32…
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FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of TX, WA, MT,…Official notice → - 2022-11-23
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Boston Scientific Neuromodulation Corporation recalls Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
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…
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