Activa® RC 37612 (UDI 00763000924638)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000924638), received between Dec 4, 2025 and May 22, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).

20 other recalls cover devices cleared under the same FDA submission (P960009); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SWELLING AT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SITE IN THEIR CHEST AFTER THE PROCEDURE AND INFLAMMATION AT THE LEAD SITE BEHIND THEIR EAR. ON (B)(6) 2026 THEY RETURNED TO THE HOSPITAL WHERE THE PHYSICIAN ASPIRATED SOME FLUID FROM THE PACEMAKER SITE IN THE CHEST AND PERFORMED DEBRIDEMENT AT THE LEAD SITE BEHIND THEIR EAR. THEY WOULD CONTINUE TO OBSERVE AND COMMUNICATE WITH THE PHYSICIAN REGARDING SUBSEQUENT TREATMENT. THE ISSUE WAS SAID TO BE RESOLVED.

  Patient problems: Fluid Discharge; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 25256935 ↗
• MalfunctionMar 24, 2026Display or Visual Feedback Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT A PATIENT WITH A MEDICAL HISTORY OF PARKINSON'S DISEASE WAS TREATED WITH DEEP BRAIN STIMULATION THERAPY. THE RECHARGER POWER INDICATOR LIGHT WAS FLASHING. THE PATIENT WAS ALIVE WITH NO INJURY, AND NOSURGICAL INTERVENTION OCCURRED OR WAS PLANNED. THE ISSUE WAS RESOLVED THROUGH A GUARANTEED REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE LIGHT WAS FLASHING GREEN. A RESET WAS PERFORMED AND WAS NOT SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676638 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL HEMORRHAGE AFTER SURGERY. FOLLOW UP TREATMENT WAS DISCUSSED WITH THE DOCTOR. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 23720347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960009. One submission often covers many models, so check the product and lot details in each record.

• Z-2241-2026 · May 13, 2026 · Open, Classified
  Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-2240-2026 · May 13, 2026 · Open, Classified
  Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-0206-2025 · Sep 24, 2024 · Open, Classified
  Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-0217-2024 · May 27, 2022 · Completed
  LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
• Z-1128-2022 · Mar 30, 2022 · Open, Classified
  Percept BrainSense Implantable Neurostimulator (INS), Model B35200
• Z-0418-2022 · Oct 19, 2021 · Open, Classified
  Model B35200 - Percept PC BrainSense Implantable Neurostimulator
• Z-0201-2022 · Sep 23, 2021 · Open, Classified
  Clinician Programmer Application (CPA) model A610 Clinician Software Application
• Z-1368-2021 · Mar 9, 2021 · Open, Classified
  A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.46
• Z-3069-2017 · Mar 17, 2017 · Terminated
  DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to
• Z-2645-2016 · Jun 23, 2016 · Terminated
  DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain
• Z-2602-2016 · Jun 10, 2016 · Terminated
  Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
• Z-1617-2015 · Apr 16, 2015 · Terminated
  Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
• Z-0279-2014 · Sep 30, 2013 · Terminated
  Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
• Z-1190-2013 · Feb 8, 2013 · Terminated
  Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system del

…and 5 more.