OPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy
The OPTIMIZER model CCM X11 implantable pulse generator may incorrectly detect a charging error and cease delivering cardiac therapy, potentially causing patients to experience heart failure symptoms. A total of 1,469 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical cardiac medical device. Although no illnesses or hospitalizations have been reported, the hazard is significant: the device may cease delivering necessary therapy, causing patients to experience serious cardiac symptoms. Per the severity rubric, Class II recalls without reported hospitalizations are typically High (3).
Plain-English summary
The OPTIMIZER model CCM X11 implantable pulse generator, manufactured by Impulse Dynamics (USA) Inc., is subject to a recall. The device may incorrectly detect a charging error and cease delivering cardiac contractility modulation (CCM) therapy. This could cause patients to experience heart failure symptoms similar to those experienced before implantation.
A total of 1,469 units have been distributed domestically throughout the United States and internationally to Austria, Croatia, Czech Republic, Germany, Italy, Macau, Poland, Romania, Russia, Spain, and Sweden. The issue affects devices using software versions 1.5.0 and 1.9.1 in both the Smart Mini and Lite models.
Patients with this device should contact their healthcare provider or Impulse Dynamics for further guidance. Do not attempt to adjust or troubleshoot the device yourself. Monitor for any worsening heart failure symptoms and seek immediate medical attention if symptoms occur.
The recalled product
- Product
- OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
- Manufacturer
- IMPULSE DYNAMICS (USA) INC
- Affected units
- 1,469
Distribution
Distributed nationwide across the United States.
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