Impulse Dynamics (USA) Inc. is recalling 1,469 OPTIMIZER Smart Mini and OPTIMIZER Lite implantable pulse generator (IPG) devices used to treat heart failure. These devices may stop delivering Cardiac Contractility Modulation (CCM) therapy if the device incorrectly detects a charging error. If therapy stops, patients may experience a return of heart failure symptoms similar to those they felt before the device was implanted. This recall affects devices with software versions 1.5.0 and 1.9.1.
The device may stop providing necessary therapy if it falsely identifies an error during the charging process, potentially causing the patient's heart failure symptoms to worsen or reappear suddenly.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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