Exclaim™ 3224 (UDI 05414734401876)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05414734401876), received between Jun 15, 2020 and Sep 22, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “High impedance” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 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. It is unknown which lead contributed to the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50859753 ↗
• InjuryFeb 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCES PREVENTING THE DEVICE FROM ENTERING MRI MODE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454627 ↗
• InjuryOct 31, 2024High impedance; Therapeutic or Diagnostic Output Failure; High impedance; Therapeutic or Diagnostic Output Failure

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 20584670 ↗
• InjurySep 18, 2023High impedance; High impedance

  ADDITIONAL INFORMATION INDICATED THAT SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 17769736 ↗
• InjuryNov 22, 2022High impedance; High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. LEAD DIAGNOSTICS INDICATED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15847872 ↗
• InjuryAug 19, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD ADDRESSING HE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15256472 ↗
• InjuryJul 22, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S THERAPY STRENGTH WAS DECREASING ON ITS OWN. DIAGNOSTICS REVELED HIGH IMPEDANCES. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15085417 ↗
• InjuryNov 5, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. IT WAS FOUND THAT THE LEAD HAD ALL CONTACTS WITH HIGH IMPEDANCE. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10794950 ↗
• InjurySep 23, 2020Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10575244 ↗
• InjurySep 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-31710. IT WAS REPORTED THE PATIENT'S SYSTEM HAD BEEN EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10562639 ↗
• InjuryAug 7, 2020Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-23758. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO A LEAD FRACTURE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. NOTE: IT IS UNKNOWN WHICH LEAD WAS FRACTURED, AS SUCH BOTH LEADS ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10382028 ↗
• InjuryAug 7, 2020Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-23757. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO A LEAD FRACTURE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. NOTE: IT IS UNKNOWN WHICH LEAD WAS FRACTURED, AS SUCH BOTH LEADS ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10381989 ↗
• InjuryJun 15, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  DEVICE 2 OF 3; REFERENCE MFR. REPORT#: 1627487-2020-21759; REFERENCE MFR. REPORT#: 1627487-2020-21761. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE STIMULATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10154869 ↗

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-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-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-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-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-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-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-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