N/A 6346Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734403252), received between Feb 12, 2025 and Sep 29, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “High impedance” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931674 ↗
• InjurySep 29, 2026Separation Failure

  It was reported that during a normal end of life IPG replacement procedure on (b)(6) 2026, the doctor was unable to remove the extensions from the IPG header. Cutting the header did not resolve the issue. As such, the extensions were explanted and replaced to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931617 ↗
• InjuryApr 24, 2025High impedance; Therapeutic or Diagnostic Output Failure; High impedance; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AUTO REDUCING. DIAGNOSTICS REVEALED HIGH IMPEDANCE ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN IPG AND EXTENSION WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Movement Disorder

  MAUDE report 21903046 ↗
• InjuryFeb 12, 2025Fracture; High impedance; Insufficient Device Problem Information; Fracture; High impedance; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT IMPEDANCE CHECK REVEALED HIGH IMPEDANCES. DURING THE PROCEDURE IT WAS IDENTIFIED THAT THE EXTENSION HAD FRACTURED.

  Patient problems: Failure of Implant; Insufficient Information; Movement Disorder; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370233 ↗
• InjuryFeb 12, 2025Fracture; High impedance; Insufficient Device Problem Information; Fracture; High impedance; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT IMPEDANCE CHECK REVEALED HIGH IMPEDANCES. DURING THE PROCEDURE IT WAS IDENTIFIED THAT THE EXTENSION HAD FRACTURED.

  Patient problems: Failure of Implant; Insufficient Information; Movement Disorder; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370012 ↗

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