Quattrode® 3143Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734401579), received between May 27, 2021 and Apr 15, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (4 reports).

14 other recalls cover devices cleared under the same FDA submission (P010032); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. NOTE : IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24884292 ↗
• InjuryMar 19, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER:1627487-2024-07623. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024 WHEREIN THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED WITH A NEW LEAD TO ADDRESS THE ISSUE. REPORTEDLY, ADEQUATE THERAPY WAS RESTORED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18935950 ↗
• InjurySep 5, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD CONTRIBUTED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685907 ↗
• InjuryAug 17, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IT WAS FOUND THAT ONE LEAD HAD HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE. NOTE: INVESTIGATION DID NOT DETERMINE WHICH LEAD HAD HIGH IMPEDANCE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15240417 ↗
• InjuryMay 27, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT HAS BEEN RECEIVING INEFFECTIVE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11896428 ↗
• InjuryMay 27, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT HAS BEEN RECEIVING INEFFECTIVE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11896416 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010032. 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-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-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-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-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-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-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-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-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
• 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-1785-2013 · Nov 30, 2012 · Terminated
  Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 reca
• Z-0025-2013 · Sep 4, 2012 · Terminated
  The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode
• Z-1738-2013 · Jul 26, 2012 · Terminated
  Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or li
• Z-3091-2011 · Jun 2, 2009 · Terminated
  Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting im