Medtronic recalls Intellis AdaptiveStim spinal cord stimulators with Product Number 97715 due to inability to reprogram one device. Affected units have UDI/DI 00643169781719.
inability to reprogram one device
Medtronic is recalling spinal cord stimulators with Product Number 97715 because one device cannot be reprogrammed. This could prevent necessary adjustments to the device's settings.
The device cannot be reprogrammed, which means adjustments to the stimulation settings may not be possible. This could affect the device's effectiveness for managing pain or other conditions.
Patients using Medtronic Intellis AdaptiveStim spinal cord stimulators with Product Number 97715 are affected. Those with the specific UDI/DI 00643169781719 are most at risk.
Check for the Product Number 97715 on the device. Affected units have the UDI/DI code 00643169781719.
Look for Product Number 97715 and UDI/DI 00643169781719 on the device.
The recall is for inability to reprogram one device, which may affect adjustments but does not pose a risk of injury.
Check for Product Number 97715 and UDI/DI 00643169781719 on the device.
The recall does not specify a remedy, so contact Medtronic for guidance.
We’ve drafted a message you can send Medtr: a short, human brand name for headings (e.g. to request your refund or repair — edit it as you like.
Subject: Recall Z-1691-2024 — Medtr: a short, human brand name for headings (e.g. Medtr: a short, human brand name for headings ( Hello, I own a Medtr: a short, human brand name for headings (e.g. that is covered by recall Z-1691-2024 from Medtr: a short, human brand name for headings (e.g.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.