Infinity™ 6661Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067020253), received between Oct 22, 2018 and Jan 12, 2022 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Premature Discharge of Battery” (2 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-2430-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THE PATIENT'S IPG HAD REACHED END OF SERVICE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE IPG WAS EXPLANTED AND REPLACED WITH NO COMPLICATIONS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13238626 ↗
• InjuryMar 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-01838. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 WHEREIN BOTH IPGS WERE EXPLANTED AND ONLY ONE IPG WAS PLACED AND RELOCATED. ISSUE RESOLVED.

  Patient problems: Implant Pain

  MAUDE report 11429639 ↗
• InjuryMar 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-01837. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 WHEREIN BOTH IPGS WERE EXPLANTED AND ONLY ONE IPG WAS PLACED AND RELOCATED. ISSUE RESOLVED.

  Patient problems: Implant Pain

  MAUDE report 11429627 ↗
• InjuryJan 24, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT 1627487-2021-00456. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCE NUMBNESS IN THEIR HAND. PROGRAMMING CHANGES WERE ATTEMPTED HOWEVER THEY WERE UNSUCCESSFUL. BOTH IMPLANTABLE PULSE GENERATORS (IPG) WERE EXPLANTED AS A RESULT AND A NEW DEVICE WAS IMPLANTED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. PATIENT WAS STABLE.

  Patient problems: Numbness

  MAUDE report 11220777 ↗
• InjuryJan 24, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT 1627487-2021-00455. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCE NUMBNESS IN THEIR HAND. PROGRAMMING CHANGES WERE ATTEMPTED HOWEVER THEY WERE UNSUCCESSFUL. BOTH IMPLANTABLE PULSE GENERATORS (IPG) WERE EXPLANTED AS A RESULT AND A NEW DEVICE WAS IMPLANTED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. PATIENT WAS STABLE.

  Patient problems: Numbness

  MAUDE report 11220775 ↗
• InjuryNov 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THERE WERE NO KNOWN ALLEGATIONS OF DEFICIENCY AGAINST THE DEVICE AS IT MET EXPECTED LONGEVITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10804966 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP INFORMATION CONFIRMED THE DURING THE REVISION, THE IPG WAS REPOSITIONED DEEPER IN THE POCKET TO RESOLVE THIS ISSUE.

  Patient problems: Pocket Erosion

  MAUDE report 10540813 ↗
• InjuryFeb 6, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENTS IPG IS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. SURGICAL INTERVENTION ADDRESSED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9678141 ↗
• InjuryNov 26, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED AND REPLACED, RESTORING THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9378780 ↗
• InjuryNov 26, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED AND REPLACED, RESTORING THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9378553 ↗
• InjuryOct 28, 2019Premature Elective Replacement Indicator; No Apparent Adverse Event; Premature Elective Replacement Indicator; No Apparent Adverse Event

  IT WAS REPORTED PATIENT RECEIVED THE REPLACE GENERATOR SOON MESSAGE. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED AND REPLACED. THERAPY RESUMED POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246770 ↗
• InjuryJun 27, 2019No Device Output; No Device Output

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IN TURN, THE PATIENT'S IPG REACHED END OF LIFE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8741033 ↗
• MalfunctionOct 22, 2018Wireless Communication Problem; Application Program Freezes or Fails to Launch; Wireless Communication Problem; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION GATHERED IDENTIFIED THE PATIENT'S IPG FAILED TO COMMUNICATE WITH THE CLINICIAN PROGRAMMER. REPORTEDLY, THE PATIENT HAS STIMULATION.

  Patient problems: Inadequate Pain Relief; No Known Impact Or Consequence To Patient

  MAUDE report 7992299 ↗

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-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