Infinity™ 5Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05415067030016), received between Apr 20, 2020 and Mar 3, 2026 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (6 reports).

2 FDA recall records name this device's identifier, 2 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-2429-2024 · Root cause: Error in labeling · FDA record ↗

2. Jul 18, 2023Open, Classified

   Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

   Z-2510-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT'S EXTENSION COILED AND TANGLED FROM IPG FLIPPING THE POCKET DUE TO TWIDDLERS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN A POUCH WAS PLACED AROUND THE IPG TO CREATE STABILITY AND THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUES.

  Patient problems: Twiddlers Syndrome

  MAUDE report 24500924 ↗
• InjuryFeb 12, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S IPG HAS REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24327950 ↗
• InjuryNov 25, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649892 ↗
• MalfunctionNov 5, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AND WOUND ISSUES AT THE LEAD SITE. AS A RESULT, THE PATIENT UNDERWENT A LEAD WASHOUT PROCEDURE ON (B)(6) 2025 TO ADDRESS THE ISSUE. DURING THE PROCEDURE, THE DEVICE WAS NOT PLACED INTO SURGERY MODE AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN ABLE TO RESOLVE THE ISSUE AND THE IPG IS OPERABLE. THE INFECTION AND WOUND ISSUE HAVE SINCE RESOLVED.

  Patient problems: Inadequate Pain Relief; Movement Disorder

  MAUDE report 23477167 ↗
• InjuryOct 29, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 23414167 ↗
• InjuryAug 20, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS REACHING END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22854594 ↗
• InjuryJun 25, 2025No Apparent Adverse Event; Unexpected Shutdown; No Apparent Adverse Event; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOTH IPGS TURNING OFF UNCOMMANDED. TROUBLESHOOTING BY COMPANY REPRESENTATIVE AND GENERATOR LOGS WERE UNABLE TO SUBSTANTIATE THE CLAIMS. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333184 ↗
• InjuryJun 25, 2025No Apparent Adverse Event; Unexpected Shutdown; No Apparent Adverse Event; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOTH IPGS TURNING OFF UNCOMMANDED. TROUBLESHOOTING BY COMPANY REPRESENTATIVE AND GENERATOR LOGS WERE UNABLE TO SUBSTANTIATE THE CLAIMS. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333158 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IPG AND EXTENSION SITE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG, AND EXTENSION WERE EXPLANTED TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION HAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 22138526 ↗
• InjuryMay 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SUSPECTED INFECTION DUE TO PUFFINESS AROUND THE IPG INCISION SITE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO INFECTION. INFECTION WAS RULED OUT.

  Patient problems: Unspecified Infection

  MAUDE report 22081961 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD AN INFECTION AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG AND EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. INFECTION HAS BEEN RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 22047699 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT EXTENSION WAS EXPOSED AND WAS AT A RISK FOR AN INFECTION. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE LEFT DBS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED BOTH ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 22024904 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS SUSPECTED INFECTION AT THE RIGHT IPG SITE. PATIENT WAS TREATED WITH IV ANTIBIOTICS AND HAD THE ENTIRE RIGHT SYSTEM EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21943349 ↗
• InjuryApr 17, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025, WHEREIN PATIENT'S IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 21861539 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THE IPG INCISION SITE HEALED AS PATIENT WAS REIMPLANTED.

  Patient problems: Pocket Erosion

  MAUDE report 21777241 ↗
• InjuryFeb 26, 2025Battery Problem; Battery Problem

  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 OCCURRED ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Failure of Implant; Movement Disorder

  MAUDE report 21473000 ↗
• InjuryJan 7, 2025Battery Problem; Battery Problem

  IT WAS REPORTED, THE IPG HAS RECEIVED THE 'ELECTIVE REPLACEMENT INDICATOR'. A MANUFACTURER REPRESENTATIVE CONFIRMED AND DEEMED THE IPG INOPERABLE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 21092805 ↗
• InjuryJan 1, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS AUTO REDUCING DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG, LEAD AND EXTENSION WERE EXPLANTED AND REPLACED.

  Patient problems: Movement Disorder; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21052206 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ENTIRE LEFT SIDE DBS SYSTEM WAS EXPLANTED AND RESULTS OF CULTURE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20898713 ↗
• InjuryNov 12, 2024Migration; Migration

  IT WAS REPORTED PATIENT'S RIGHT EXTENSION CAUSED THE IPG TO ROTATE AND COIL DUE TO THE SILK TIE PULLING THROUGH THE HEADER, RESULTING IN HIGH IMPEDANCES AND BREAK. TO ADDRESS THE ISSUE, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE RIGHT EXTENSION WAS EXPLANTED AND REPLACED AND A NEW SILK TIE WAS ADDED TO THE OTHER HEADER TIE DOWN. THERAPY WAS RESTORED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668546 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 DURING WHICH THE IPG WAS REPOSITIONED WITH NO COMPLICATIONS. IT IS UNKNOWN WHICH IPG HAD THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 20340099 ↗
• InjuryApr 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS FLIPPING THE IPG AND THE ANCHORING SUTURES HAD TORN FREE OF THE TISSUE. THIS CAUSED DISCOMFORT FOR THE PATIENT. IN TURN, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024 WHEREIN THE IPG WAS PLACED DEEPER IN THE POCKET AND SECURE TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain; Twiddlers Syndrome

  MAUDE report 19199256 ↗
• InjuryDec 14, 2022Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT HAD HER LEFT DBS IPG REPLACED ON (B)(6) 2022 BECAUSE OF UNKNOWN REASONS.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 15983487 ↗
• InjurySep 14, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG VALUE SHOWED AS ABNORMAL. SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15422660 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PHYSICIAN UNDERWENT SURGICAL INTERVENTION TO REMOVE THE PATIENT'S RIGHT LEAD AND EXTENSION WITH NO COMPLICATIONS. NO REMAINING INFECTION ISSUES WERE TOLD OF.

  Patient problems: Unspecified Infection

  MAUDE report 12511186 ↗

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-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-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-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.