Infinity™ 6660Recalls & reported problems

Summary

The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 05415067020246), received between Jun 20, 2018 and Mar 13, 2026 — classified as 5 deaths, 277 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (99 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 312 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 24591418 ↗
• InjuryDec 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2025 IN WHICH THEIR IPGS WERE EXPLANTED AND REPLACED FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 23936739 ↗
• InjuryDec 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON AN UNKNOWN DATE WHEREIN THE IPG WAS REPLACED FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 23792118 ↗
• InjuryDec 4, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM HAD IMPEDANCES ISSUES AND THE IPG WAS UNABLE TO ENTER MRI MODE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED, RESOLVING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717684 ↗
• InjuryNov 24, 2025High impedance; High impedance

  IT WAS REPORTED THE PATIENT IS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES AND UNABLE TO SET IPG TO MRI MODE. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXTENSION AND IPG WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631929 ↗
• InjuryNov 11, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT HAS LOW IMPEDANCE ON THE RIGHT SIDE. PHYSICIAN BELIEVES IT IS CAUSED BY FLUID IN THE IPG HEADER. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526450 ↗
• InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION REPORTED PATIENT'S IPG WAS EXPLANTED DUE TO IPG REACHING END OF LIFE. IT WAS UNKNOWN IF THIS OCCURRED PREMATURELY. PATIENT EXTENSION WAS EXPLANTED DUE TO HIGH IMPEDANCES AND FRACTURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486249 ↗
• InjurySep 9, 2025Migration; Migration

  IT WAS REPORTED THAT BOTH IPGS MIGRATED. IT WAS ALSO REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, ONE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000780 ↗
• InjuryAug 24, 2025Migration; Migration

  IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. IT WAS ALSO REPORTED THAT THE IPG MIGRATED AND PATIENT EXPERIENCED PAIN AT THE IPG SITE. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

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

  MAUDE report 22881704 ↗
• InjuryAug 24, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. IT WAS ALSO REPORTED THAT THE IPG MIGRATED AND PATIENT EXPERIENCED PAIN AT THE IPG SITE. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Movement Disorder

  MAUDE report 22881703 ↗
• InjuryAug 4, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON LEFT CONTACT. IT IS UNCLEAR IF THE HIGH IMPEDANCES WERE PRESENT ON THE LEAD EXTENSION OR THE IPG. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHEREIN BOTH THE LEFT LEAD EXTENSION AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 22709983 ↗
• InjuryJul 30, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT'S SYSTEMS HAD LOW IMPEDANCES ON THE LEFT SIDE, AND HIGH IMPEDANCES ON THE RIGHT SIDE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN IT WAS DISCOVERED THAT THE LEFT EXTENSION PULLED OUT FROM THE IPG, AND THE RIGHT LEAD PULLED OUT FROM THE EXTENSION. THE LEFT EXTENSION WAS REINSERTED INTO THE IPG, AND THE RIGHT LEAD WAS REINSERTED INTO THE RIGHT EXTENSION TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22671703 ↗
• InjuryJul 11, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT PATIENTS IPG ENTERED SERVICE APP MODE FOR AN UNKNOWN REASON, IPG WAS RECOVERED, AND THERAPY WAS RESTORED. PATIENTS IPG THEN ENTER SERVICE APP MODE AGAIN, SEVERAL DAYS LATER, AGAIN FOR AN UNKNOWN REASON. AT THIS TIME THE DEVICE IS UNABLE COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22484944 ↗
• InjuryJul 10, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT¿S LEFT IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22475713 ↗
• InjuryJun 4, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DUE DURING A NORMAL END OF LIFE IPG REPLACEMENT PROCEDURE ON (B)(6) 2025, THE EXTENSION STUCK IN THE IPG HEADER. THE EXTENSION COULD NOT BE DISCONNECTED FROM THE HEADER. AS SUCH, THE EXTENSION WAS EXPLANTED ALONG WITH THE IPG TO ADDRESS THE ISSUE. THERAPY WAS CONFIRMED POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144922 ↗
• InjuryMay 9, 2025Battery Problem; Wireless Communication Problem; Battery Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG HAD CONNECTION ISSUES WITH EXTERNAL DEVICES. IN TURN, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS SITUATION.

  Patient problems: Failure of Implant; Inadequate Pain Relief; Movement Disorder; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998463 ↗
• InjuryApr 21, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT DIAGNOSTICS INDICATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED EARLIER THAN INTENDED. THE DEVICE HAD THE APPROPRIATE LEVEL OF BATTERY VOLTAGE TO PROVIDE THERAPY. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 21877648 ↗
• InjuryApr 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES, PATIENT'S INFECTION HAS RESOLVED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 21870430 ↗
• InjuryMar 6, 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 WAS UNDERTAKEN ON (B)(6) 2025 TO REPLACE THE IPG. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Failure of Implant; Movement Disorder

  MAUDE report 21540848 ↗
• InjuryFeb 26, 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 OCCURRED ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED RESOLVING THE ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 21472962 ↗
• InjuryFeb 23, 2025Battery Problem; Battery Problem

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

  Patient problems: Failure of Implant

  MAUDE report 21442833 ↗
• InjuryFeb 23, 2025Battery Problem; Battery Problem

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

  Patient problems: Failure of Implant

  MAUDE report 21442831 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED ANXIETY AND COMMITTED SUICIDE AFTER A DBS IMPLANT. PATIENT DID RECEIVE ADEQUATE PSYCHIATRIC CARE AND SPECIFIC MEDICATIONS.

  Patient problems: Anxiety; Suicidal Ideation

  MAUDE report 21381778 ↗
• InjuryFeb 3, 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 MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Movement Disorder

  MAUDE report 21300644 ↗
• InjuryJan 30, 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 BILATERAL IPG SITES IN THEIR ABDOMEN. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHEREIN BOTH THE IPGS WERE EXPLANTED AND REPLACED WITH A SINGLE DBS IPG TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 21279582 ↗

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-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
• 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