NA 2321Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 05415067016713), received between Sep 11, 2018 and Apr 24, 2026 — classified as 145 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (43 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 147 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE CHANNEL ADAPTER SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON 02APR2026 WHEREIN THE CHANNEL ADAPTERS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24990345 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE CHANNEL ADAPTER SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026, WHEREIN THE CHANNEL ADAPTERS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24990343 ↗
• InjuryApr 23, 2026High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ADAPTERS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24965648 ↗
• InjuryApr 23, 2026High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ADAPTERS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24965643 ↗
• InjuryApr 11, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY FROM BOTH OF THEIR SCS SYSTEMS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD OR ADAPTER IS RESPONSIBLE FOR INEFFECTIVE THERAPY OF EITHER SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24852014 ↗
• InjuryApr 1, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT EXPERIENCED LOSS OF EFFECTIVE THERAPY DUE TO LOW IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24758507 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT BOTH THE IPG AND LEAD SITES. SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS, AND THE INFECTION HAS SINCE RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 23660327 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE ADAPTER SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED. THE INFECTION HAS RESOLVED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23059838 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE ADAPTER SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED. THE INFECTION HAS RESOLVED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23059835 ↗
• InjuryAug 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT'S SCS ADAPTERS DISCONNECTED FROM THE IPG. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ADAPTERS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22799173 ↗
• InjuryAug 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT'S SCS ADAPTERS DISCONNECTED FROM THE IPG. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ADAPTERS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22799158 ↗
• InjuryJun 3, 2025Disconnection; Therapeutic or Diagnostic Output Failure; Disconnection; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE IPG SITE. REPORTEDLY, THE IPG HEADER COULD NOT SECURE THE ADAPTER. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025, WHEREIN THE IPG WAS REPOSITIONED AND IPG HEADER RECONNECTED TO ANOTHER ADAPTER TO ADDRESS THE ISSUE. REPORTEDLY, THE DISCONNECTED ADAPTER WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22136778 ↗
• InjuryMay 16, 2025Break; Corroded; Break; Corroded

  ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT'S ADAPTER WAS CORRODING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033353 ↗
• InjuryApr 28, 2025Low impedance; Low impedance

  IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO LOW IMPEDANCES ON LEAD AND COMPETITOR'S LEAD. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21923554 ↗
• InjuryMar 17, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN IPG REPOSITIONING ON (B)(6)2025, (RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2025-01926), THE PHYSICIAN WAS UNABLE TO ADVANCE THE ADAPTERS BECAUSE THEY WERE PLIABLE. AS A RESULT, THE ADAPTERS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627552 ↗
• InjuryMar 17, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN IPG REPOSITIONING ON (B)(6) 2025, (RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2025-01926), THE PHYSICIAN WAS UNABLE TO ADVANCE THE ADAPTERS BECAUSE THEY WERE PLIABLE. AS A RESULT, THE ADAPTERS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627550 ↗
• InjuryDec 26, 2024Inappropriate/Inadequate Shock/Stimulation; No Apparent Adverse Event; Inappropriate/Inadequate Shock/Stimulation; No Apparent Adverse Event

  IT WAS REPORTED PATIENT EXPERIENCED SHOCKING AT THE LEAD SITE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Undesired Nerve Stimulation

  MAUDE report 21023892 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS HAVING DISCOMFORT AT THE SITE OF THE EXTENSIONS. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 19918047 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS HAVING DISCOMFORT AT THE SITE OF THE EXTENSIONS. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 19918045 ↗
• InjuryApr 24, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND INEFFECTIVE STIMULATION. AS SUCH SURGICAL INTERVENTION TOOK PLACE WHERE THE ENTIRE SYSTEM WAS EXPLANTED APPROXIMATELY ON (B)(6) 2024.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19176336 ↗
• InjuryApr 24, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND INEFFECTIVE STIMULATION. AS SUCH SURGICAL INTERVENTION TOOK PLACE WHERE THE ENTIRE SYSTEM WAS EXPLANTED APPROXIMATELY ON (B)(6) 2024.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19176334 ↗
• InjuryFeb 16, 2024High impedance; High impedance

  ABBOTT REP REPORTS INVESTIGATION SHOWS CONTINUED IMPEDANCE ISSUES. SURGERY MAY TAKE PLACE FOR REVISION OF DEVICE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18725385 ↗
• InjuryJan 30, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER: 3006705815-2024-00801. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY AND POCKET STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT AND REPLACE THE SYSTEM. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY. THE ALLEGATION IS AGAINST 1 OF 2 ADAPTERS; HOWEVER, IT IS UNKNOWN WHICH ADAPTER, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: BSX ADAPTER, MODEL: 2321ANS, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7297399.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18603746 ↗
• InjuryDec 7, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18281979 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-07854. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-05738. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 18255738 ↗

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-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-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-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-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