Intracept RF Probe RLV 0015Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00852454006219), received between Dec 10, 2024 and Aug 11, 2026 — classified as 2 deaths, 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a Basivertebral Nerve (BVN) Radiofrequency Ablation (RFA) procedure, the patient experienced airway obstruction and decreased oxygen saturation, which occurred throughout the procedure. The patient was repositioned to a supine position and was assessed and treated by medical staff. The patient's condition improved, and oxygen saturation returned to within normal limits. The procedure was completed as planned. The patient was transferred to the Post-Anesthesia Care Unit and was reported to be stable.

  Patient problems: Airway Obstruction; Hypoxia

  MAUDE report 50204130 ↗
• InjuryAug 7, 2026Use of Device Problem

  It was reported that during the basivertebral nerve (BVN) radiofrequency ablation (RFA) procedure, the RF probe became contaminated after contact with the C-arm following the first ablation. The contaminated probe was replaced with another device, allowing the procedure to be successfully completed. Postoperatively, the patient is doing well. No further information has been obtained at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180579 ↗
• MalfunctionJul 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25864591 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH, HYPOXIA, AND SLIGHT TACHYCARDIA, LEADING TO HOSPITAL ADMISSION. THE PATIENTS MEDICAL HISTORY IS SIGNIFICANT FOR CONGESTIVE HEART FAILURE, ATRIAL FIBRILLATION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND OBSTRUCTIVE SLEEP APNEA. LABORATORY TESTING WAS POSITIVE FOR RESPIRATORY SYNCYTIAL VIRUS (RSV). THE PATIENT WAS TREATED WITH DUONEB, SOLU-MEDROL, AND FUROSEMIDE, AND UNDERWENT ELECTROCARDIOGRAM AND LABORATORY EVALUATIONS. THE PATIENT REMAINED HOSPITALIZED FOR TWO NIGHTS AND WAS STABILIZED WITH DIURETIC THERAPY BEFORE BEING DISCHARGED. THE EVENT IS REPORTED TO HAVE RESOLVED. THE REPORTED EVENT OCCURRED APPROXIMATELY FOUR MONTHS AFTER THE INTRACEPT BVN (BASIVERTEBRAL NERVE) ABLATION WAS PERFORMED. THE REPORTED EVENT WAS ASSESSED AS NOT BEING RELATED TO THE DEVICE OR PROCEDURE.

  Patient problems: Dyspnea; Hypoxia; Tachycardia

  MAUDE report 25292741 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRACEPT PROCEDURE WAS COMPLETED, THE PATIENT EXPERIENCED A TEMPERATURE OF 99.5 DEGREES, SYMPTOMS OF SHIVERING AND FEELING COLD, AND PAIN DURING URINATION. THE PHYSICIAN PRESCRIBED ANTIBIOTICS FOR THE PATIENT'S SYMPTOMS. THE PHYSICIAN ASSESSED THE PATIENT'S SYMPTOMS AS NOT BEING RELATED TO THE DEVICE OR PROCEDURE; HOWEVER, THE ROOT CAUSE OF THE PATIENT'S SYMPTOMS WAS UNKNOWN. THE PATIENT'S SYMPTOMS RESOLVED THE NEXT DAY AND IT WAS NOTED THAT THERE WERE NO DEVICE ISSUES DURING THE INTRACEPT PROCEDURE. ALL DEVICES USED DURING THE PROCEDURE WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR DEVICE ANALYSIS.

  Patient problems: Chills; Dysuria; Fever

  MAUDE report 24473947 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT WAS HOSPITALIZED FOR SPELL CHARACTERIZATION. IT IS UNKNOWN IF THE EVENT IS RELATED TO THE DEVICE OR PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS EVENT WAS DETERMINED TO BE A PLANNED ADMISSION FOR SEIZURE MONITORING. THE EVENT WAS ASSESSED AS BEING NOT RELATED TO DEVICE OR PROCEDURE.

  Patient problems: Insufficient Information; Syncope/Fainting

  MAUDE report 23985927 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEY SUSTAINED INJURIES DUE TO THE DEVICE AND/OR PROCEDURE. NO FURTHER INFORMATION REGARDING THE EVENT OR DEVICE CAN BE OBTAINED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946153 ↗
• MalfunctionOct 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED HARD BONE AND THE CURVED CANNULA PEEK BROKE OFF INSIDE THE PATIENT. IT COULD NOT BE CONFIRMED WHETHER DEVICE FRAGMENTS WERE CONTAINED INSIDE THE BONE OR OUTSIDE THE BONE. IT WAS NOTED THAT A NEW INTRACEPT KIT WAS NOT OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23262439 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO EXPERIENCING NEW POST-OPERATIVE LEG PAIN THAT WAS SEVERE. THE PATIENT WAS SEEN BY MULTIPLE SPECIALISTS WITH NO CLEAR ETIOLOGY. THE PATIENT LATER WENT TO A CLINIC TO SEE A PHYSICIAN. THE PATIENTS LEG WEAKNESS AND PAIN SYMPTOMS WERE RESOLVED. THE PATIENT STATES THERE IS A SMALL AREA OF NUMBNESS IN THEIR FOOT. IT WAS NOTED THAT THE PATIENTS INTRACEPT PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO REPORTED DEVICE ISSUES. IN ADDITION, THE DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Muscle Weakness/Atrophy; Numbness; Pain

  MAUDE report 22877901 ↗
• DeathAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE AND A FIFTEEN MINUTE ABLATION WAS PERFORMED WITHOUT COMPLICATION. HOWEVER, WHEN A SECOND ABLATION WAS INITIATED, THE ANESTHESIA TEAM IDENTIFIED COMPLICATIONS AND REQUESTED THE PROCEDURE BE STOPPED. THE ABLATION WAS IMMEDIATELY HALTED AND THE ANESTHESIA TEAM INITIATED RESUSCITATIVE EFFORTS. THE EMERGENCY MEDICAL SERVICES (EMS) ARRIVED AND TRANSPORTED THE PATIENT TO THE HOSPITAL. THE HOSPITAL CALLED TIME OF DEATH UPON THE PATIENT'S ARRIVAL. THE PHYSICIAN ASSESSED THAT NEITHER THE DEVICE NOR THE PROCEDURE CONTRIBUTED TO THE PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822313 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE DYSESTHETIC LEG PAIN THAT OCCURRED TWO WEEKS AFTER UNDERGOING AN INTRACEPT PROCEDURE. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS HOSPITALIZED FOR A FEW DAYS DUE TO SEVERE PAIN. POST-OPERATIVE IMAGING WAS PERFORMED AND SHOWED NO NERVE COMPRESSION OR COMPLICATIONS. IT WAS FOUND THAT THE PATIENT HAD A SELECTIVE NERVE ROOT BLOCK AND THE PAIN WAS RESOLVED.

  Patient problems: Pain

  MAUDE report 22760887 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE DYSESTHETIC LEG PAIN THAT OCCURRED TWO WEEKS AFTER UNDERGOING AN INTRACEPT PROCEDURE. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS HOSPITALIZED FOR A FEW DAYS DUE TO SEVERE PAIN. POST-OPERATIVE IMAGING WAS PERFORMED AND SHOWED NO NERVE COMPRESSION OR COMPLICATIONS. IT WAS FOUND THAT THE PATIENT HAD A SELECTIVE NERVE ROOT BLOCK AND THE PAIN WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT HAVE A PRIOR HISTORY OF LEG PAIN OR MRI FINDINGS OF NERVE IMPINGEMENT.

  Patient problems: Pain

  MAUDE report 22760863 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PATIENT'S AIRWAY BECAME COMPROMISED AND THE PATIENT NEEDED TO BE FLIPPED BACK SUPINE TO RESTORE THEIR AIRWAY. THE PROCEDURE WAS ABORTED AND RESCHEDULED AT A LATER DATE. THE PATIENT WAS SEDATED WITH GENERAL ANESTHESIA. THE PHYSICIAN ASSESSED THE EVENT AS NOT BEING RELATED TO THE DEVICE OR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Airway Obstruction; Insufficient Information

  MAUDE report 22377568 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INTRACEPT PROCEDURE, THE PATIENT EXPERIENCED SEVERE SCIATIC PAIN. THE PATIENT WAS TREATED WITH GABAPENTIN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Pain

  MAUDE report 22178897 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE PAIN THE DAY AFTER UNDERGOING AN INTRACEPT PROCEDURE. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT (ED) BECAUSE THEY COULD NOT GIVE HER ANY MORE PAIN MEDICATION. THERE WERE NO REPORTED DEVICE ISSUES AND THE PATIENT DID NOT HAVE ANY POST-OPERATIVE COMPLICATIONS, JUST UNCONTROLLED POSTOPERATIVE PAIN. THE PATIENT HAS DENIED WANTING TO UTILIZE ORAL STEROIDS DUE TO PREVIOUS SIDE EFFECTS. THE PATIENT WAS STILL EXPERIENCING POST-OPERATIVE DISCOMFORT BUT IS SLOWLY IMPROVING. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Pain

  MAUDE report 22015604 ↗
• InjuryApr 15, 2025Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PATIENT WAS SEDATED UNDER MONITORED ANESTHESIA CARE (MAC). IT WAS NOTED THAT THE PATIENT HAD A BIG BELLY AND HARD TIME BREATHING. THE PATIENT WAS FLIPPED OVER AND THE PHYSICIAN DECIDED TO ABORT THE CASE. THE PATIENT WAS STABLE POSTOPERATIVELY AND THERE WERE NO FURTHER ISSUES.

  Patient problems: Insufficient Information; Respiratory Insufficiency

  MAUDE report 21845084 ↗
• InjuryApr 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING MIGRAINES AND PAIN AFTER THE INTRACEPT PROCEDURE. PATIENT STATED THAT HE IS A HARD LABORER AND STARTED TO LIFT MORE AT WORK. SHORTLY AFTER THAT, THE PATIENT EXPERIENCED NEW BACK PAIN AND HEADACHES BEGAN AT NIGHT. THE PATIENT NOTED THAT HE ONLY FEELS PAIN WHEN HE MOVES, NOT WHEN HE IS LYING DOWN. THE PATIENT WAS REFERRED TO HIS PRIMARY CARE PHYSICIAN (PCP) FOR ELEVATED BLOOD PRESSURE AND LATER ADMITTED HIMSELF TO THE EMERGENCY ROOM (ER) A FEW DAYS LATER. THE PATIENT WAS GIVEN PRESCRIPTION MEDICATIONS BUT COULD NOT REMEMBER WHAT THEY WERE FOR. THE PATIENT WAS KEPT OVERNIGHT AT THE ER AND WAS RELEASED THE NEXT DAY. SEVERAL TESTS WERE PERFORMED INCLUDING A MAGNETIC RESONANCE IMAGING (MRI) WITH CONTRAST. ALL TESTS CAME BACK NEGATIVE.

  Patient problems: Headache; High Blood Pressure/ Hypertension; Insufficient Information; Pain

  MAUDE report 21821151 ↗
• InjuryApr 2, 2025Disconnection; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Disconnection; Impedance Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PROBE HAD AN ERROR CODE 25 AND AN IMPEDANCE ERROR DURING THE FIRST BURN. NO LEVELS WERE COMPLETED PRIOR TO THE PROBE ERRORS OCCURRING AND THE PATIENT WAS SEDATED WITH MONITORED ANESTHESIA CARE (MAC) ANESTHESIA. WHEN THE PHYSICIAN REMOVED THE PROBE AND TRIED TO RECONNECT IT TO THE GENERATOR, THE ERROR CODE 25 APPEARED ON THE GENERATOR DISPLAY AND THERE APPEARED TO BE A DISCONNECTION FROM THE ELECTRODE IN THE PROBE. THE PHYSICIAN REMOVED THE WHOLE SYSTEM AND THE PROBE WAS FULLY INTACT WITH NO SIGNS OF DAMAGE TO THE SHEATH. AFTER AN UNSUCCESSFUL ATTEMPT TO DOCK AT L5, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757455 ↗
• DeathMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INTRACEPT PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, THE PATIENT HAD AN ISSUE WITH THE ANESTHESIA. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER) POST-PROCEDURE. THE PATIENT PASSED AWAY AFTER SOME ANESTHESIA CHALLENGES POST-PROCEDURE. THE PHYSICIAN ACKNOWLEDGED THAT THE PATIENTS DEATH WAS NOT A PROCEDURE OR DEVICE-RELATED COMPLICATION. NO DEVICES WILL BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 21656127 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BASIVERTEBRAL NERVE ABLATION AT MULTIPLE LEVELS. THE PHYSICIAN COMPLETED THE CASE SUCCESSFULLY. HOWEVER, AFTER THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR A RETROPERITONEAL BLEED. THE PHYSICIAN ORDERED A COMPUTED TOMOGRAPHY (CT) SCAN WITH AN ANGIOGRAM, WHICH SHOWED A LUMBAR ARTERY ANEURYSM. THE PATIENT RECEIVED AN EMBOLIZATION IN RADIOLOGY. ALL DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED, AS THERE WERE NO REPORTED DEVICE ISSUES. THE PATIENT IS DOING WELL POSTOPERATIVELY AND HAS NO COMPLICATIONS.

  Patient problems: Aneurysm; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21639167 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  IT WAS REPORTED THAT THE INTRACEPT PROCEDURE DID NOT PROVIDE EFFECTIVE PAIN RELIEF FOR THE PATIENT. THE PATIENT EXPERIENCED PAIN, DIFFICULTY WALKING, AND A FRACTURE AFTER THE PROCEDURE. IMAGING WAS NOT PROVIDED AND AS A RESULT, THE PATIENT'S FRACTURE COULD NOT BE CONFIRMED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL UNDERGO A KYPHOPLASTY. THE FRACTURE WAS IDENTIFIED AT A FOLLOW-UP VISIT POSTOPERATIVELY.

  Patient problems: Bone Fracture(s); Movement Disorder; Pain

  MAUDE report 20896850 ↗