Infinity™ 6662Recalls & reported problems

Summary

The FDA's MAUDE database contains 803 adverse event reports that list this exact device (DI 05415067020260), received between Jun 12, 2018 and Aug 4, 2026 — classified as 3 deaths, 746 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (377 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 22, 2024Open, Classified

   Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

   Z-2431-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 803 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient¿s extensions exhibited high impedances prior to the procedure. Patient was diagnosed with twiddler's syndrome. As a result, surgical intervention was undertaken wherein the extensions were untwisted and the IPG was replaced to address the issue.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50125713 ↗
• InjuryJun 8, 2026Wireless Communication Problem

  IT WAS REPORTED DURING AN I&D PROCEDURE, THE IPG BECAME INOPERABLE. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Movement Disorder

  MAUDE report 25435778 ↗
• InjuryMay 26, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT PATIENT'S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. DURING THE PROCEDURE THE EXTENSION PULLED OUT OF THE EXTENSION CONNECTION. THE IPG AND EXTENSION WERE EXPLANTED AND REPLACED.

  Patient problems: Movement Disorder

  MAUDE report 25285145 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED 21 DAYS FOLLOWING A DBS STIMULATOR IMPLANT. THE CAUSE OF DEATH WAS NOT REPORTED, THOUGH THE PATIENT WAS REPORTED TO HAVE PARKINSON'S AND CANCER.

  Patient problems: Insufficient Information

  MAUDE report 25179828 ↗
• InjuryMar 31, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THEIR ENTIRE SYSTEM EXPLANTED AND REPLACED WITH A COMPETITOR SYSTEM FOR AN UNKNOWN REASON ON AN UNKNOWN DATE.

  Patient problems: Insufficient Information

  MAUDE report 24747434 ↗
• InjuryMar 31, 2026Low impedance

  IT WAS REPORTED PATIENT EXPERIENCED OVER STIMULATION AND LOW IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746149 ↗
• InjuryMar 30, 2026Wireless Communication Problem

  IT WAS REPORTED PATIENT'S IPG LOST COMMUNICATION WITH ALL EXTERNAL DEVICES FOLLOWING A FALL. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24736942 ↗
• InjuryMar 24, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24675285 ↗
• InjuryMar 20, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650412 ↗
• InjuryMar 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545813 ↗
• InjuryFeb 26, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED, RESOLVING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456181 ↗
• InjuryFeb 23, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 24422252 ↗
• InjuryFeb 18, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN IPG WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 24380066 ↗
• InjuryJan 20, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEFT LEAD HAD IMPEDANCES. ADDITIONALLY, THE PATIENT WAS UNABLE TO ENTER MRI MODE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEFT IPG WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122139 ↗
• InjuryJan 2, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM IS EXHIBITING LOW IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951788 ↗
• InjuryDec 26, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO LOW IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Movement Disorder

  MAUDE report 23898443 ↗
• InjuryDec 16, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Movement Disorder

  MAUDE report 23817923 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED A SKIN INFECTION OVER THE IPG SITE. TO ADDRESS THE ISSUE, THE IPG AND EXTENSIONS WERE EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23623697 ↗
• InjuryNov 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN IPG REPLACEMENT ON (B)(6) 2025, THE EXTENSION COULD NOT BE TAKEN OUT OF THE CHANNEL 1 OF THE IPG. AS SUCH, THE PHYSICIAN HAD TO CUT THE IPG'S HEADER AND THE END THE SCREW BLOCK FROM CHANNEL 1 OF THE INFINITY COULD NOT BE TAKEN OUT OVER THE END OF THE EXTENSION SO IT WAS LEFT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581010 ↗
• InjuryNov 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THEIR IPG EXPLANTED IN 2024 AT AN UNKNOWN DATE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 23549505 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Implant Pain

  MAUDE report 23493648 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION. IT WAS DETERMINED THAT THE PATIENT TWIDDLED BOTH OF THE IPGS RESULTING IN LEFT EXTENSION FRACTURED AND RIGHT EXTENSION WAS TWISTED. AS RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH IPGS AND BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Twiddlers Syndrome

  MAUDE report 22896330 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION. IT WAS DETERMINED THAT THE PATIENT TWIDDLED BOTH OF THE IPGS RESULTING IN LEFT EXTENSION FRACTURED AND RIGHT EXTENSION WAS TWISTED. AS RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH IPGS AND BOTH EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Twiddlers Syndrome

  MAUDE report 22896327 ↗
• InjuryAug 14, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY FROM THE LEFT LEAD, AND RECEIVED A LOW BATTERY WARNING. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812001 ↗
• InjuryAug 11, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS UNABLE TO CONNECT TO ITS EXTERNAL DEVICES. TROUBLESHOOTING WAS ABLE TO RESOLVE THAT ISSUE. SURGICAL INTERVENTION WAS THEN UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Movement Disorder

  MAUDE report 22777402 ↗

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-0459-2026 · Oct 6, 2025 · Open, Classified
  Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
• 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-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-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
• 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.