OPTIMIZERRecalls & reported problems across all models

We found 3 models of OPTIMIZER by Impulse Dynamics (usa) Inc. in the FDA's device registry (GUDID). Together they are named in 149 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2023 and Sep 27, 2026 — classified as 2 deaths, 96 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (26 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

OPTIMIZER recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 5, 2024Open, Classified

   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.

   Z-1173-2024 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported OPTIMIZER problems

OPTIMIZER models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OPTIMIZER Smart Mini

  Implantable Pulse Generator
  1 recall2 deaths125 reports
• OPTIMIZER Lite

  Implantable Pulse Generator
  1 recall5 reports
• OPTIMIZER™ CCM X10

  Implantable Pulse Generator
  19 reports

Recent OPTIMIZER adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910420 ↗
• MalfunctionSep 17, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811010 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  An Impulse Dynamics field representative reported that after a second lead dislodgement occurred in a patient implanted with an OPTIMIZER Lite IPG, the patient and doctor agreed to have the IPG and leads removed. The rep attended the explant procedure. The explanted IPG was returned to Impulse Dynamics USA in Marlton, NJ for evaluation. There is no evidence at this time that the IPG was malfunctioning at the time of explant. It is unclear as to the reason(s) why the leads repeatedly dislodged in this patient (ex. anatomy, Twiddler's, etc.) prior to system explant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793418 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pericardial Effusion

  MAUDE report 50793059 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  An Impulse Dynamics field representative was informed on (b)(6) 2026 that a patient implanted with an OSM IPG had their device explanted during a lead extraction procedure. In the process of removing both pacing leads from the left ventricle, the physician decided to explant the entire implanted system, which included the OSM IPG. The IPG was discarded by the hospital after explant and is therefore not available for evaluation. There is no evidence at this time to indicate device malfunction prior to explant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50592173 ↗
• MalfunctionAug 27, 2026Failure to Charge

  A clinician's office called an Impulse Dynamics field representative saying a patient reported to them that their implanted OS IPG "did not work." The ID rep called the patient and the patient said that their device was reporting numbers so the patient thought it was not working and "had not charged "[it]" in months." The ID rep advised the patient to attempt to charge their device and keep the rep posted.The patient was seen in-person by the rep the following week. The ID rep interrogated the patient's IPG and found the device had reverted off due to "high current." No sensing was able to be measured on the LS lead. Because of that, no impedances were able to be measured. It was recommended to the patient that they discuss with their physician the need for a lead revision. The patient is planning to be seen by their physician next month to discuss a possible lead revision.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50486076 ↗
• InjuryAug 14, 2026Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258207 ↗
• InjuryAug 14, 2026Failure to Charge

  This OS IPG was explanted on (b)(6) 2026. Previously, the patient reported that during last charging process, the device's battery indicator on the charger screen always remained at 4 bars. The patient continued to perform weekly charging in the last weeks even though they had no feedback from the charger battery indicator lights. An in-clinic follow-up resulted in this same charger behaviour despite the Impulse Dynamics field representative's use of either the patient's charger or FCE charger. The IPG could not be interrogated using any available programmer; no blinking feedback light on the programmer wand turned on, and only the standby light was on. Only a couple of times, the charger was able to communicate with the device for a few seconds, resulting in an Error Code 2. It was decided by the patient's physician the IPG would be replaced, which occurred on (b)(6) 2026. The explanted IPG is expected to be received by Impulse Dynamics for further evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258206 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by an Impulse Dynamics field representative based in Germany that during a lead revision procedure of a patient implanted with an OS IPG, the physician wanted to upgrade the device to an OSM IPG. This was performed; the OS IPG was explanted and replaced with a new OSM IPG. The OS IPG was functioning properly before being swapped but was scrapped by the hospital after explant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258205 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50258204 ↗
• InjuryAug 14, 2026Misassembly by Users

  During an initial implantation procedure of an OSM IPG, the physician needed to reposition a lead after connecting IPG to both leads. The set screws were backed out too far and fell out of the threads. Impulse Dynamics field representatives attempted to guide the physician through the process of re-seating the screw. Physician attempted to remove the seal plug to re-seat the set screw but in doing so damaged the seal plug. A backup device was provided and was successfully connected to the leads after lead repositioning was complete. The original IPG was decontaminated at an approved decontamination facility before being returned to Impulse Dynamics USA for evaluation. Damage was observed on the seal plug of the V1 distal setscrew which was consistent with the reported complaint description. After removing the damaged seal plug the setscrew was able to tighten down successfully. Visual inspection of the setscrew revealed no stripping or other damage. All 6 setscrews were then tightened to full depth and backed out without any issues. Testing of the electronic controls passed all checks. The root cause of this issue was determined to be user error during the implant procedure. During

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258203 ↗
• InjuryAug 14, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258202 ↗
• InjuryAug 14, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258201 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258200 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258199 ↗