OPTIMIZER™ CCM X10Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00810003380050), received between Aug 28, 2024 and Sep 16, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Charge” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pericardial Effusion

  MAUDE report 50793059 ↗
• 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 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, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258202 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an OS IPG reported feeling pocket stimulation from both leads. During the lead revision procedure to address this, the physician reportedly cut his glove and felt that the OS IPG that had been previously implanted had been possibly compromised. He therefore requested a new CCM device be implanted. The patient was subsequently implanted with a new OSM IPG without complication. The original OS IPG was scrapped by the hospital and was therefore unavailable for evaluation. There is no evidence the OS IPG previously malfunctioned prior to explant.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50258198 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 50258172 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a patient implanted with an OS IPG became septic and as a result required their IPG to be explanted. The explanted IPG was decontaminated at an approved decontamination facility before being returned to Impulse Dynamics USA for evaluation. Device interrogation confirmed the IPG was functional at the time of explant and it passed all electronic controls testing. There is no evidence to suggest the IPG caused or contributed to the onset of the patient's sepsis.

  Patient problems: Sepsis

  MAUDE report 50258158 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50258155 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: Insufficient Information

  MAUDE report 50258149 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a patient outside the United States had their OS IPG removed after not showing echocardiographic or other clinical improvement while the device was implanted. The IPG was explanted without complications and was returned to Impulse Dynamics USA for evaluation after being decontaminated at an approved decontamination facility. Device interrogation revealed that no down modes or failures had occurred, and the device passed all final electronic controls testing. The root cause investigation determined was that there was nothing wrong with the device and it was only explanted because no significant clinical improvement to the patient was observed.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50258143 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  During a normal follow-up appointment, the lead impedance on a patient's implanted OS IPG was found to be >2000 on both leads. X-Rays were taken and it was confirmed the patient twiddled the device, the second time this had reportedly occurred according to the physician. The physician opted to have the patient's IPG removed. The explanted IPG was scrapped by the hospital and was therefore unavailable for evaluation. However, a DHR review was conducted and no anomalies were found. It is known that twiddling may cause attached IPG leads to become damaged or dislodged.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50258141 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an OS IPG developed an MSSA infection and required the device to be removed. The device was explanted as a precaution, as the physician stated the staph was not caused by device. The explanted IPG was discarded and was therefore not available for evaluation. A DHR review was conducted and no anomalies were found.

  Patient problems: Bacterial Infection

  MAUDE report 50258131 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Viral Infection

  MAUDE report 50258126 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258122 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was discovered during a 10-day post-operative check that the patient developed a pocket infection. The patient subsequently had their implanted OS IPG and concomitant ICD removed. The explanted IPG was decontaminated and returned to Impulse Dynamics USA, Inc. for evaluation. No issues were found with the IPG and it passed electronic controls testing. A DHR review conducted, and no anomalies were found, including any in the device sterilization records.

  Patient problems: Medical device site infection

  MAUDE report 50258116 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was initially reported that a patient implanted with an OS IPG had their device deactivated during an Impella implantation procedure. The patient initially requested the OS IPG be turned back on, but before they could be seen in-person by an Impulse Dynamics field representative, they underwent a heart transplant. The explanted OS IPG was discarded by the hospital and is thus not available for evaluation. However, there is no evidence at this time to suggest the IPG had been malfunctioning prior to the Impella procedure and subsequent explant.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50073623 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON MARCH 4, 2025, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE IN THE EU WAS INFORMED OF A DEVICE EXPLANT THAT HAD TAKEN PLACE ON (B)(6) 2025. THE PATIENT'S OPTIMIZER SMART (OS) IMPLANTABLE PULSE GENERATOR (IPG) AND ATTACHED LEADS WERE EXPLANTED DUE TO THE PATIENT'S SEPTIC CONDITION. THE IPG AND LEADS WERE SCRAPPED BY THE HOSPITAL AND ARE THUS UNAVAILABLE FOR EVALUATION. A REVIEW OF THE DHR, INCLUDING WAS CONDUCTED AND NO ANOMALIES WERE FOUND. THERE IS NO EVIDENCE TO INDICATE THE PATIENT'S OS IPG CAUSED OR CONTRIBUTED TO THE SEPSIS.

  Patient problems: Sepsis

  MAUDE report 21561290 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. ON MARCH 4, 2025, IT WAS CONFIRMED THAT THE DEVICE HAD BEEN SCRAPPED BY THE HOSPITAL AFTER EXPLANT. THEREFORE, A FULL PRODUCT EVALUATION OF THE DEVICE WILL NOT BE POSSIBLE. THERE REMAINS NO EVIDENCE TO SUGGEST THE OS IPG IMPLANTED THREE YEARS PRIOR CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION THAT DEVELOPED AROUND THEIR CRT-D DEVICE.

  Patient problems: Bacterial Infection

  MAUDE report 20091339 ↗