NA 16000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05415067040756), received between Jan 31, 2024 and Sep 16, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Melted” (13 reports).

19 other recalls cover devices cleared under the same FDA submission (P010032, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Melted

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796544 ↗
• MalfunctionFeb 19, 2026Melted

  IT WAS REPORTED PATIENT WAS UNABLE TO CHARGE THE SYSTEM BECAUSE THE CHARGER HAD A WIRE MELTED. A REPLACEMENT CHARGER WAS SENT TO PATIENT TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394962 ↗
• InjuryDec 2, 2025Melted; Melted

  IT WAS REPORTED THAT THE CHARGING PORT OF THE PATIENT'S CHARGER MELTED. AS A RESULT, A REPLACEMENT CHARGER WAS SENT, AND PATIENT WAS ABLE TO RECHARGE THE IPG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690113 ↗
• InjuryNov 4, 2025Melted; Melted

  IT WAS REPORTED THAT THE PATIENT'S IPG CHARGER HAD A SMELL OF "BURNING PLASTIC" WHEN PLUGGED INTO THE WALL AND THE CHARGING ADAPTER HEATED UP AND MELTED. A REPLACEMENT IPG CHARGER WAS SENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468335 ↗
• MalfunctionSep 11, 2025Melted; Melted

  IT WAS REPORTED THAT THE PATIENT'S GENERATOR CHARGER MELTED. AS A RESULT, A REPLACEMENT CHARGER MAY BE SENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23034705 ↗
• MalfunctionAug 29, 2025Melted; Melted

  IT WAS REPORTED THAT THE CHARGER GOT HOT WHILE CHARGING, AND THE CHARGER PORT MELTED WITH PART OF THE CHARGING CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929137 ↗
• MalfunctionJul 9, 2025Melted; Melted

  IT WAS REPORTED THAT THE PATIENT'S CHARGER PORT MELTED. THE PATIENT WAS SHIPPED A REPLACEMENT CHARGER UNDER WARRANTY TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460426 ↗
• MalfunctionMay 1, 2025Melted; Melted

  IT WAS REPORTED THAT THE EXTERNAL DEVICE CHARGING PORT MELTED. THERE WAS NO REPORTED HARM TO THE PATIENT. THE DEVICE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943218 ↗
• InjuryApr 21, 2025Melted; Melted

  IT WAS REPORTED THAT THE PATIENT'S CHARGER STARTED MELTING WHEN PLUGGED IN TO THE WALL TO CHARGE. A REPLACEMENT CHARGER WAS DELIVERED TO ADDRESS THE ISSUE. THE PATIENT WAS NOT HARMED IN ANY WAY BY THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874884 ↗
• MalfunctionApr 17, 2025Melted; Melted

  IT WAS REPORTED THAT THE PATIENT'S CHARGER AND CHARGING CABLE MELTED TOGETHER. THE PATIENT WAS PROVIDED A REPLACEMENT AND EXPERIENCED NO ADVERSE EFFECTS RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853730 ↗
• MalfunctionMar 25, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED PATIENT NOTICED THAT WHEN CHARGER WAS PLUGGED IN CHARGER GETS HOT QUICKLY AND SMELLS OF SOMETHING BURNING. THEY HAVE ALSO NOTED BLACK DOTS APPEARING ON THE BLUE LABEL. AS SUCH THE CHARGER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687700 ↗
• MalfunctionJan 31, 2025Melted; Melted

  IT WAS REPORTED THAT PATIENTS CHARGING CABLE MELTED. PATIENT EXPERIENCED NO HARM. PRODUCT WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21288927 ↗
• MalfunctionJan 31, 2025Melted; Melted

  IT WAS REPORTED THAT WHEN ATTEMPTING TO CHARGE CHARGER, PATIENTS CHARGING CABLE AND A PORT ON PATIENT'S CHARGER MELTED. PATIENT EXPERIENCED NO HARM. PRODUCT WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21288924 ↗
• MalfunctionJan 31, 2025Melted; Melted

  IT WAS REPORTED THAT WHEN ATTEMPTING TO CHARGE CHARGER, PATIENTS CHARGING CABLE AND A PORT ON PATIENT'S CHARGER MELTED. PATIENT EXPERIENCED NO HARM. PRODUCT WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21288921 ↗
• MalfunctionJan 31, 2024Smoking; Smoking

  IT WAS REPORTED THE PATIENTS CHARGER EMITTED SMOKE DURING THE CHARGING SEQUENCE. NO ADVERSE CONSEQUENCES TO THE PATIENT. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616007 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010032, P140009. One submission often covers many models, so check the product and lot details in each record.

• Z-0458-2026 · Oct 6, 2025 · Open, Classified
  Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
• Z-0459-2026 · Oct 6, 2025 · Open, Classified
  Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
• Z-2505-2023 · Jul 18, 2023 · Open, Classified
  Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electr
• Z-2506-2023 · Jul 18, 2023 · Open, Classified
  Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device
• Z-2511-2023 · Jul 18, 2023 · Open, Classified
  Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
• Z-2508-2023 · Jul 18, 2023 · Open, Classified
  Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
• Z-2507-2023 · Jul 18, 2023 · Open, Classified
  Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
• Z-2510-2023 · Jul 18, 2023 · Open, Classified
  Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
• Z-2509-2023 · Jul 18, 2023 · Open, Classified
  Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extens
• Z-2692-2017 · Jun 2, 2017 · Terminated
  Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
• 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-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-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-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-2691-2017 · Jun 2, 2017 · Terminated
  Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c

…and 4 more.