Exclaim™ 3225 (UDI 05415067017758)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05415067017758), received between Jul 17, 2018 and Apr 29, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “High impedance” (14 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS SHOWED HIGH IMPEDANCES. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25033478 ↗
• InjurySep 2, 2025High impedance; High impedance

  ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22948021 ↗
• InjuryJul 26, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S CERVICAL PADDLE LEAD HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025, WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22621773 ↗
• InjuryFeb 1, 2024High impedance; High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY/COVERAGE DUE TO HIGH IMPEDANCE ON THE LEAD. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18622595 ↗
• InjurySep 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN IPG REPLACEMENT, THE PHYSICIAN NOTICED THE LEAD WAS FRACTURED. AS A RESULT, THE PHYSICIAN IS REFERRING THE PATIENT TO A SURGEON FOR A LEAD REPLACEMENT TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 17725323 ↗
• InjuryJun 15, 2023Migration; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED RESTORING THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17133581 ↗
• InjuryMay 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S CERVICAL SCS LEAD HAD FRACTURED. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 17005326 ↗
• InjuryJan 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO LEAD FRACTURE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN AT UNKNOWN DATE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT WAS FRACTURED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16086683 ↗
• InjuryDec 29, 2022Migration; Migration

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-02147, 1627487-2023-02148. ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 IN WHICH THEIR PADDLE LEAD WAS EXPLANTED AND REPLACED. DURING THE PROCEDURE THE PATIENT'S QUATTRODE LEADS WERE ALSO REMOVED DUE TO SCARRING AROUND THE LEADS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16070333 ↗
• InjuryDec 29, 2022High impedance; High impedance

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION TOOK PLACE IN WHERE THE LEAD WAS REPLACED. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4).

  Patient problems: Inadequate Pain Relief

  MAUDE report 16068455 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-13600. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 14043594 ↗
• InjuryDec 10, 2021High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.

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

  MAUDE report 12976023 ↗
• InjuryApr 22, 2021High impedance; Migration; High impedance; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A CAR ACCIDENT, THE LEADS MIGRATED, AND HIGH IMPEDANCES WERE MEASURED AT THE LEAD CONTACTS. X-RAY IMAGING CONFIRMED MIGRATION OCCURRED, AND THE BOTTOM OF THE LEAD MOVED OUT OF THE EPIDURAL SPACE. AS A RESULT, SURGERY OCCURRED IN WHICH THE LEAD WAS EXPLANTED AND REPLACED, WHICH RESOLVED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11704867 ↗
• InjuryJan 19, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO THE LEAD MIGRATING OUT OF THE EPIDURAL SPACE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11196794 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MANUFACTURER NUMBER: 3006705815-2020-33390. IT WAS REPORTED THAT THE PATIENT'S BODY REJECTED THEIR SCS SYSTEM LIKELY DUE TO AN ALLERGIC RESPONSE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE DEVICES WERE EXPLANTED ON AN UNKNOWN DATE TO ADDRESS THE ISSUE. NOTE: SINCE IT IS NOT KNOWN WHICH DEVICE CONTRIBUTED TO THE ISSUE, ALL POSSIBLE DEVICES ARE BEING REPORTED ON.

  Patient problems: Inflammation

  MAUDE report 11065821 ↗
• InjuryNov 11, 2020Break; Therapeutic or Diagnostic Output Failure; Break; Therapeutic or Diagnostic Output Failure

  FOLLOW UP INFORMATION RECEIVED THAT THE PATIENT HAD THE LEAD EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10826126 ↗
• InjuryNov 11, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S CERVICAL PADDLE LEAD HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10822803 ↗
• InjuryNov 8, 2020Fracture; High impedance; Migration; Fracture; High impedance; Migration

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2021. THE PHYSICIAN NOTED THAT THE LEAD WAS FRACTURED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10807021 ↗
• InjuryOct 13, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS AUTO REDUCING DUE TO HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10673277 ↗
• InjurySep 22, 2020Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  ADDITIONAL INFORMATION INDICATES THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10568249 ↗
• InjuryAug 17, 2020Fracture; High impedance; Fracture; High impedance

  MANUFACTURER REPORT REFERENCE NUMBER: 1627487-2020-24094, 1627487-2020-24096. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION IN WHICH THE LEADS WERE EXPLANTED AND REPLACED WITH ONE PENTA LEAD. DURING THE PROCEDURE IT WAS NOTED THAT THE EXCLAIM LEADS WERE VISIBLY FRACTURED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10416237 ↗
• InjuryAug 4, 2020High impedance; High impedance

  IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION AND DIAGNOSTICS INDICATED HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED. THIS ADDRESSED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10364254 ↗
• InjuryJul 28, 2020Fracture; Fracture

  IT WAS REPORTED THE PATIENT¿S SYSTEM WAS EXPLANTED AND REPLACED DUE TO A LEAD FRACTURE. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10334034 ↗
• InjuryJun 10, 2020High impedance; High impedance

  IT WAS REPORTED THE PATIENT'S SCS LEAD WAS EXHIBITING HIGH IMPEDANCE ON MULTIPLE CONTACTS. REPORTEDLY, THE PATIENT STATED THEY HAD A SEIZURE APPROXIMATELY THREE MONTHS PRIOR AND FELL, THE SCS SYSTEM HAS NOT WORKED SINCE. CONSEQUENTLY, SURGICAL INTERVENTION WAS TAKEN AND THE PATIENT'S SCS LEAD WAS SUCCESSFULLY REPLACED WITH A NEW ONE AND THE REPORTED ISSUE RESOLVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10136578 ↗
• InjuryAug 2, 2019High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-08751. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. X-RAYS WERE INCONCLUSIVE. AS A RESULT, THE SYSTEM WAS EXPLANTED AND REPLACED. ISSUE RESOLVED

  Patient problems: Inadequate Pain Relief

  MAUDE report 8856276 ↗

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-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-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-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-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