Impulse Dynamics recalls OPTIMIZER CCM X11 implantable pulse generators (Smart Mini and Lite models) that may stop therapy due to charging errors, risking heart failure symptoms.
OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.
Impulse Dynamics is recalling OPTIMIZER model CCM X11 implantable pulse generator devices (Smart Mini and Lite) because they may stop delivering therapy if the device incorrectly detects a charging error. This could cause heart failure symptoms similar to those before the device was implanted.
The device may stop delivering critical cardiac therapy if it incorrectly identifies a charging error. This can lead to heart failure symptoms that resemble pre-implantation conditions.
Patients with OPTIMIZER CCM X11 implantable pulse generator devices (Smart Mini and Lite models) are affected. Those with the specific software versions 1.5.0 or 1.9.1 are at higher risk.
Check for the OPTIMIZER Smart Mini UDI-DI: 00810003380098 or OPTIMIZER Lite UDI-DI: 00810003380142. The affected devices have software versions 1.5.0 or 1.9.1.
Verify your device's software version; affected units have versions 1.5.0 or 1.9.1.
Reach out to Impulse Dynamics for guidance on next steps if your device is affected.
Software versions 1.5.0 and 1.9.1 are affected.
Check for the OPTIMIZER Smart Mini UDI-DI: 00810003380098 or OPTIMIZER Lite UDI-DI: 00810003380142, or confirm your software version is 1.5.0 or 1.9.1.
No immediate stop is required; contact Impulse Dynamics for specific guidance if your device is affected.
We’ve drafted a message you can send Impulse Dynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1173-2024 — Impulse Dynamics Impulse Dynamics Hello, I own a Impulse Dynamics that is covered by recall Z-1173-2024 from Impulse Dynamics. 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.
