Proclaim™ 3672Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 05415067046406), received between Mar 9, 2023 and Aug 25, 2026 — classified as 115 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (34 reports).

2 FDA recall records name this device's identifier, 2 still open.

13 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.

Recalls naming this device

1. May 16, 2024Open, Classified

   The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

   Z-2366-2024 · Root cause: Vendor change control · FDA record ↗

2. Jul 18, 2023Open, Classified

   Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

   Z-2508-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Wireless Communication Problem

  It was reported that following unrelated surgical procedures wherein it is unknown whether the device was placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting was unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50440073 ↗
• InjuryAug 25, 2026Wireless Communication Problem

  It was reported that following an unrelated surgical procedure wherein the device was not placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting was unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50436878 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain at the IPG site. Additionally, the patient experienced ineffective therapy. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50124151 ↗
• InjuryJul 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THEIR SYSTEM EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 25774184 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMATOMA AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Hematoma

  MAUDE report 25717102 ↗
• InjuryJun 8, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT FOLLOWING RECENT WEIGHT LOSS AND TAKING A FALL, THE PATIENT EXPERIENCED SHOCKING SENSATIONS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE EXTENSIONS AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 25423152 ↗
• InjuryJun 1, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE DUE TO THE IPG MIGRATING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS REPOSITIONED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 25352823 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE SYSTEM WAS EXPLANTED ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 25285664 ↗
• InjuryMay 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED ORAL ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25196111 ↗
• InjuryMay 4, 2026Migration

  IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT AT THE IPG SITE DUE TO THE IPG FLIPPING IN ITS POCKET. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 25076208 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATES THE INFECTION HAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 25069659 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING RECENT WEIGHT LOSS, THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 25028470 ↗
• InjuryApr 23, 2026Wireless Communication Problem

  IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING 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 24966817 ↗
• InjuryApr 22, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAS REACHED ITS END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. STIMULATION WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24955556 ↗
• InjuryApr 16, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT¿S IPG IS REACHING END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900731 ↗
• InjuryApr 9, 2026Wireless Communication Problem

  IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING 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 24830458 ↗
• InjuryApr 3, 2026Wireless Communication Problem

  A RESTROSPECTIVE REVIEW INDICATES THIS EVENT IS CONNECTED TO THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) PROCLAIM¿ SCS FAMILY, PROCLAIM¿ DRG THERAPY AND INFINITY¿ DBS SYSTEMS SURGERY MODE ADVISORY NOTICE ISSUED BY ABBOTT ON 02 APRIL 2026.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24781461 ↗
• InjuryApr 2, 2026Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE FOLLOWING AN UNRELATED PROCEDURE. THE PATIENT DID NOT SET THE IPG TO SURGERY MODE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24772393 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS REPOSITIONED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 24654754 ↗
• InjuryMar 9, 2026Premature Discharge of Battery; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24552173 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE IPG SITE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 24491204 ↗
• InjuryMar 2, 2026Premature Discharge of Battery; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24490279 ↗
• InjuryFeb 20, 2026Migration

  IT WAS REPORTED THAT PATIENT EXPERIENCED BURNING SENSATION AT THE IPG SITE, X-RAY IMAGING REVEALED IPG WAS FLIPPED IN POCKET AND LEADS WERE TWISTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Burning Sensation

  MAUDE report 24405287 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE DUE TO WEIGHT LOSS. AS A RESULT SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS REPOSITIONED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 24395589 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 24379928 ↗

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-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-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-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-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-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