IMPULSE DYNAMICS (USA) INC recalls OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
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.
Read the official notice →- Date
- 2024-02-28
- Country
- United States
- Brand
- IMPULSE DYNAMICS (USA) INC
- Product
- OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
- Classification
- Class II
- Units
- Domestic US distribution nationwide. International distribution to Austria…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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