Penta™ 3228 (UDI 05415067017253)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,201 adverse event reports that list this exact device (DI 05415067017253), received between Jun 11, 2018 and Sep 30, 2026 — classified as 11 deaths, 5,168 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1,120 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 25 most recent of 5,201 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50952812 ↗
• InjurySep 29, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: Inadequate Pain Relief

  MAUDE report 50940433 ↗
• InjurySep 29, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: Inadequate Pain Relief

  MAUDE report 50939794 ↗
• InjurySep 29, 2026High impedance

  It was reported that the patient experienced ineffective therapy due to high impedances on the lead. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50936400 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported patient was experiencing lead erosion through the skin. The patient¿s lead was revised on 15SEP2026. Therapy was restored post-op.

  Patient problems: Erosion

  MAUDE report 50935672 ↗
• InjurySep 28, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924669 ↗
• InjurySep 28, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: Inadequate Pain Relief

  MAUDE report 50923276 ↗
• InjurySep 28, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient experienced ineffective therapy. As a result, surgical intervention was undertaken on an unknown date wherein the system was explanted to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50923221 ↗
• InjurySep 28, 2026High impedance

  It was reported that the patient was unable to place their system into MRI mode and experienced ineffective therapy. Diagnostics revealed high impedance on the lead. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50916747 ↗
• InjurySep 28, 2026High impedance

  It was reported patient experienced ineffective stimulation and inability to enable MRI mode. Diagnostics showed high impedances on the lead. As a result, the lead was explanted and replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50913984 ↗
• InjurySep 25, 2026Impedance Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50905883 ↗
• InjurySep 25, 2026Impedance Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50903266 ↗
• InjurySep 25, 2026High impedance

  Patient problems: Inadequate Pain Relief

  MAUDE report 50902461 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following implanting procedure, patient experienced epidural hematoma. As result, surgical intervention was undertaken wherein the entire system was explanted to address the issue.

  Patient problems: Hematoma; Muscle Weakness/Atrophy; Urinary Incontinence

  MAUDE report 50893013 ↗
• InjurySep 24, 2026Migration

  Patient problems: Inadequate Pain Relief

  MAUDE report 50892465 ↗
• InjurySep 24, 2026High impedance

  Patient problems: Inadequate Pain Relief

  MAUDE report 50890966 ↗
• InjurySep 24, 2026High impedance

  It was reported the patient was not receiving effective therapy due to high impedances and unable to set IPG to MRI mode. Surgical intervention was undertaken wherein the lead was explanted and replaced. Effective therapy was established.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50883650 ↗
• InjurySep 23, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: Inadequate Pain Relief

  MAUDE report 50874695 ↗
• InjurySep 23, 2026High impedance

  It was reported that the patient was unable to place their system into MRI mode. Diagnostics revealed high impedances on the lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was explanted and replaced to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872320 ↗
• InjurySep 23, 2026Migration

  It was reported that patient experienced weakness on his hand. Patient's lead migrated. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50871764 ↗
• InjurySep 22, 2026Migration

  It was reported that the patient experienced ineffective therapy. X-ray imaging revealed migration of the lead. As a result, surgical intervention was undertaken on (b)(6) 2026 to reposition the lead.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50859487 ↗
• InjurySep 22, 2026High impedance

  It was reported that the lead had unresolved high impedances. Therapy was still effective after reprogramming. Surgical intervention was undertaken where the lead was replaced to resolve the impedance issue. Date of procedure is not known.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50854752 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50847713 ↗
• InjurySep 21, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient experienced ineffective therapy. Reprogramming has been unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50847510 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an MRSA infection. As a result, surgical intervention was undertaken on (b)(6) 2026 where system was removed to address the issue.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50828671 ↗

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-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-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-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-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-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-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