Exclaim™ 3225 (UDI 05414734401883)Recalls & reported problems

Summary

The FDA's MAUDE database contains 246 adverse event reports that list this exact device (DI 05414734401883), received between Jun 12, 2018 and Sep 30, 2026 — classified as 1 death, 240 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (77 reports).

14 other recalls cover devices cleared under the same FDA submission (K063080, 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 246 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient reported that the lead placed as trial to perm lead required an extended hospital stay during the trail and now does not have effective therapy as the lead has migrated and system is not working at this time. Patient reports no communication, but it is not known if the charging was maintained. As a result, surgical intervention may be taken at a later date.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50948561 ↗
• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient experienced shocking sensations. Evaluation of the system indicated high impedances on multiple contacts. As a result, surgical intervention may be undertaken to address the issue. It is unknown which lead is related to this issue.

  Patient problems: Burning Sensation

  MAUDE report 50901218 ↗
• InjurySep 18, 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 was undertaken wherein system was explanted to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50813435 ↗
• InjuryAug 5, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient experienced ineffective therapy, shocking sensations, numbness in the extremities, vasovagal syncope, cardiac event and atrial fibrillation. As a result, surgical intervention was undertaken on an unknown date wherein the entire system was explanted to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50147495 ↗
• InjuryAug 3, 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 entire system was explanted to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50122451 ↗
• InjuryJun 16, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S CERVICAL LEAD EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN IN (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. AFTER EXPLANT, IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT LEAD INCISION SITE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25527839 ↗
• InjuryJun 3, 2026High impedance

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEAD HAS HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25384249 ↗
• InjuryApr 16, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE INEFFECTIVE THERAPY. PATIENT¿S LEAD HAD MIGRATED. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN THE LEAD WAS REPOSITIONED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24905592 ↗
• InjuryApr 12, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT REPORTED INEFFECTIVE STIMULATION. DIAGNOSTIC REPORTS INDICATED THE LEAD HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24853014 ↗
• InjuryApr 3, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24779205 ↗
• InjuryMar 4, 2026High impedance; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEAD HAS HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514267 ↗
• InjuryFeb 25, 2026Malposition of Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO MALPOSITION OF THE DEVICE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24445287 ↗
• InjuryFeb 19, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24393509 ↗
• InjuryFeb 19, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24393503 ↗
• InjuryFeb 13, 2026High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24339843 ↗
• InjuryJan 27, 2026High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24196368 ↗
• InjuryJan 26, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 24185172 ↗
• InjuryJan 20, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PERM IMPLANT PROCEDURE ON (B)(6) 2025 THE PATIENT¿S LEAD WAS CUT IN ACCIDENT AND THE CASE WAS ABANDONED. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHEREIN THE SEVERED LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123745 ↗
• InjuryJan 12, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS CONFIRMED FRACTURED. AS A RESULT, THE IPG AND LEAD WERE EXPLANTED AND REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24047140 ↗
• InjuryDec 28, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ONE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS AND ANCHORS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23904038 ↗
• InjuryDec 17, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT'S LEADS HAD IMPEDANCE ISSUES. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEADS WERE EXPLANTED AND REPLACED. THE IPG WAS REPLACED FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835235 ↗
• InjuryNov 17, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS AND INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23576649 ↗
• InjuryNov 7, 2025High impedance; High impedance

  ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025, WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23504018 ↗
• InjuryOct 24, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND THE IPG WAS UNABLE TO COMMUNICATE WITH THE EXTERNAL DEVICES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23377988 ↗
• InjurySep 12, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE LEAD WAS LEFT IMPLANTED, THE IPG WAS EXPLANTED, AND THE SYSTEM WAS REPLACED WITH A COMPETITOR'S SYSTEM TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23034883 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063080, 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-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-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-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-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-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-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-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