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U.S. Department of Health and Human Services

Class 2 Device Recall OPTIMIZER Smart Mini and OPTIMIZER Lite

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  Class 2 Device Recall OPTIMIZER Smart Mini and OPTIMIZER Lite see related information
Date Initiated by Firm January 05, 2024
Date Posted February 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1173-2024
Recall Event ID 93791
PMA Number P180036S021 P180036S025 
Product Classification Implantable pulse generator - Product Code QFV
Product OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Code Information OPTIMIZER Smart Mini UDI-DI: 00810003380098 OPTIMIZER Lite UDI-DI: 00810003380142 All units potentially affected. The available software versions that allow the issue to manifest are 1.5.0 and 1.9.1.
Recalling Firm/
Manufacturer		 IMPULSE DYNAMICS USA INC
523 Fellowship Rd Ste 230
Mount Laurel NJ 08054-3418
For Additional Information Contact Dr. Robert Fasciano
617-435-9098
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action On January 2, 2024, the firm sent letters to field representatives to be given to affected physicians. Summary of the safety communication can be found online: https://impulse-dynamics.com/safety-information/ The firm recommends all patients with implant card showing model CCM X11, who have experienced the "A9" charge error, charge their implanted device to no more than 75% of full capacity to circumvent the issue. See link above for instructions. If a patient encounters an A9 error code, CCM therapy has been suspended and must be manually reset. Patients should schedule time with an Impulse Dynamics representative or their physician to manually reset their device. The firm is working on a software update to address this issue. Patients and clinicians may determine if a specific device is affected by providing the serial number of any specific device to the Technical Support Hotline at 866-312-5370.
Quantity in Commerce 1,469 total units
Distribution Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = QFV and Original Applicant = Impulse Dynamics (USA), Inc.
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