Liberta RC™ 62400Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 05415067047663), received between Jun 7, 2024 and Sep 15, 2026 — classified as 1 death, 27 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Unintended Application Program Shut Down” (73 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (P140009); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 6, 2025Class IIOpen, Classified

   There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

   Z-0459-2026 · Root cause: Process control · Recall details · FDA record ↗

2. May 16, 2024Class IIOpen, Classified

   Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.

   Z-2265-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Premature Discharge of Battery

  It was reported the patient¿s IPG had an increased recharge burden. As a result, surgical intervention was undertaken wherein the IPG was replaced on (b)(6) 2026 to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772380 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CARDIAC COMPLICATIONS FOLLOWING THEIR IMPLANT PROCEDURE AND IT RESULTED IN TWO ELECTRICAL CARDIOVERSIONS. ALL SYMPTOMS HAVE NOW RESOLVED AND THERAPY WAS RESTORED.

  Patient problems: Arrhythmia

  MAUDE report 24665385 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CARDIAC COMPLICATIONS FOLLOWING THEIR IMPLANT PROCEDURE AND IT RESULTED IN TWO ELECTRICAL CARDIOVERSIONS. ALL SYMPTOMS HAVE NOW RESOLVED AND THERAPY WAS RESTORED.

  Patient problems: Arrhythmia

  MAUDE report 24650546 ↗
• InjuryFeb 27, 2026High impedance

  IT WAS REPORTED PATIENT EXPERIENCED HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEFT EXTENSION AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476698 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT'S SYSTEM WAS INFECTED AT THE BURR HOLE AND IPG POCKET SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24381141 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE IPG SITE. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24363570 ↗
• InjuryJan 27, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT FOLLOWING SEVERAL FALLS, THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 24195724 ↗
• DeathJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY WITHIN 30 DAYS OF AN ABBOTT PROCEDURE. THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); No Clinical Signs, Symptoms or Conditions

  MAUDE report 24090144 ↗
• InjuryDec 19, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS RETURNED. THE IPG WAS UNABLE TO PROPERLY COMMUNICATE WITH EXTERNAL DEVICES AND DISPLAYED A CHARGE DISCREPANCY. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 23851465 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT'S IPG SITE WAS SWELLING. PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2025 WHEREIN IPG SITE WAS OPENED AND CLEANED OUT WHAT APPEARED TO BE A HEMATOMA. THERAPY WAS RESTORED POST-OP.

  Patient problems: Hematoma

  MAUDE report 23794292 ↗
• InjuryDec 9, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM NEVER ESTABLISHED EFFECTIVE THERAPY DUE TO INCREASING IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Movement Disorder

  MAUDE report 23760855 ↗
• InjuryDec 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A IPG REPLACEMENT ON (B)(6) 2025 FOR AN UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 23697433 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THE LEAD HAD ERODED AT THE BURR HOLE SITE. THIS DEVICE IS NO LONGER CONSIDERED REPORTABLE.

  Patient problems: Erosion

  MAUDE report 23582788 ↗
• InjuryNov 11, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT HAD LOW IMPEDANCES FOLLOWING THEIR IPG REPLACEMENT ON (B)(6) 2025. THE PATIENT THEN UNDERWENT SURGICAL INTERVENTION IN WHICH THEIR STITCHES WERE REOPENED AND THE IMPEDANCES RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525935 ↗
• InjuryNov 5, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 23480090 ↗
• InjuryNov 4, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEATING AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Burning Sensation

  MAUDE report 23469159 ↗
• InjurySep 10, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT'S THERAPY WAS TURNING OFF AND ON. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief; Movement Disorder

  MAUDE report 23019975 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED. THE PATIENT RECEIVED IV ANTIBIOTICS AND WAS HOSPITALIZED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22561601 ↗
• MalfunctionJun 16, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THE PATIENTS IPG IS DISPLAYING INCORRECT CHARGE VALUES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. THE NEXT COURSE OF ACTION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214373 ↗
• MalfunctionMay 29, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG IS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. THE PATIENT HAS THERAPY AND THERE IS NO INTERVENTION PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106377 ↗
• InjuryApr 28, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM HAD INVALID IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922527 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN MRSA INFECTION AT THE LEFT IPG SITE. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025, WHEREIN THE IPG WAS EXPLANTED. ADDITIONALLY, PATIENT WAS GIVEN ORAL ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21910940 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE INFECTION HAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 21900925 ↗
• InjuryApr 22, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENT'S LEAD HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE IPG WAS DISCOLORED, IPG WAS EXPLANTED AND REPLACED DURING THE PROCEDURE TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886618 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG SITE. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 21575390 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140009. One submission often covers many models, so check the product and lot details in each record.

• Z-2694-2017 · Jun 2, 2017 · Terminated
  Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
• Z-2695-2017 · Jun 2, 2017 · Terminated
  Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
• Z-2693-2017 · Jun 2, 2017 · Terminated
  Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions.
• Z-2696-2017 · Jun 2, 2017 · Terminated
  Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I