OPTIMIZER LiteRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810003380142), received between Dec 3, 2024 and Sep 17, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Misassembly by Users” (2 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258200 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE WAS INFORMED THAT A PATIENT HAD THEIR OSM IPG AND LEADS EXPLANTED THAT DAY. THE PATIENT HAD DEVELOPED AN INFECTION AROUND THEIR IMPLANTED PORT-A-CATH DEVICE, WHICH HAD BEEN IMPLANTED DUE TO THE PATIENT'S ONGOING CANCER TREATMENT. THE PHYSICIAN ELECTED TO EXPLANT ALL OF THE PATIENT'S IMPLANTED DEVICES, WHICH INCLUDED AN OSM IPG. HOSPITAL BLOOD CULTURES IDENTIFIED BACTEREMIA AS THE TYPE OF INFECTION AROUND THE PORT-A-CATH. THE EXPLANTED OSM IPG AND LEADS ARE CURRENTLY BEING HELD UNDER QUARANTINE AT THE HOSPITAL. THE IPG IS EXPECTED TO BE RECEIVED BY IMPULSE DYNAMICS USA IN (B)(6) IN THE COMING WEEKS TO BE FURTHER EVALUATED. THERE IS NO EVIDENCE AT THIS TIME TO INDICATE THE IPG CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

  Patient problems: Bacteremia

  MAUDE report 23513489 ↗
• MalfunctionDec 3, 2024Installation-Related Problem; Installation-Related Problem

  DURING THE IMPLANTATION OF AN OPTIMIZER LITE (OL) IMPLANTABLE PULSE GENERATOR, IT WAS DETERMINED THAT THE PATIENT'S LEADS REQUIRED INTRAOPERATIVE ADJUSTMENT. THE SURGEON RETRACTED THE SET SCREWS OF THE V1 AND V2 LEADS, BUT UPON RE-ENGAGEMENT AND TIGHTENING, THE V1 LEAD WAS UNABLE TO BE INSERTED. THIS WAS ATTRIBUTED TO THE INABILITY OF ITS DISTAL SET SCREW TO BE TIGHTENED. THE SURGEON STATED "THE SET SCREW HAD BEEN RETRACTED TOO FAR AND HAD BECOME MISALIGNED WITH THE BORE AND THREADS." AT THAT POINT, THE DEVICE WAS DISCONNECTED FROM BOTH LEADS AND SWAPPED WITHOUT INCIDENT. THE UNUSED DEVICE WILL BE RETURNED TO (B)(4) FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832380 ↗