Intracept RLV0065Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00852454006424), received between Jan 13, 2026 and Sep 25, 2026 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 22, 2026Class IIOpen, Classified

   Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.

   Z-2694-2026 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Atrial Fibrillation; Chest Pain; Cough; Tachycardia

  MAUDE report 50900356 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after the basivertebral nerve (BVN) radiofrequency ablation (RFA) procedure transverse process, fracture at the vertebral levels treated were noted. Based on the physicians assessment, the procedure did contribute to the adverse event. The procedure was completed as planned without any device malfunction and there was not any medical intervention. Post operatively, the patient is stable and currently, there is no next course of action. The device will not return for analysis as it was discarded by the medical facility.

  Patient problems: Vertebral Fracture

  MAUDE report 50900349 ↗
• InjurySep 23, 2026Difficult to Advance

  It was reported that during a basivertebral nerve (BVN) radiofrequency ablation (RFA) procedure, the patient experienced bleeding upon removal of the access cannula. The patient had a history of scoliosis, and the physician initially docked using an anteroposterior (AP) approach on the lateral aspect of the pedicle. Subsequent lateral imaging indicated that the cannula was positioned further into the pedicle than originally suspected and may have been in a parapedicular or extrapedicular location. The physician continued advancement with a mallet but determined that the cannula was too loose to safely proceed. The physician elected to return to the AP view and establish a new docking point. Upon removal of the access cannula, a large volume of blood was observed exiting the cannula. The physician indicated that the bleeding may have been associated with injury to an arterial blood vessel. The procedure was aborted at that time. The patient was reported to be doing well following the event. The device was retained and is not expected to be returned for analysis.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 50871267 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that prior the basivertebral nerve (BVN) radiofrequency ablation (RFA) procedure for vertebrogenic pain there was a problem with patient positioning that created an anesthesia concern, therefore the patient was flipped back onto the bed to ensure safety and stabilization. Once patient was stable, the physicians elected to continue the procedure. Physician began procedure at S1 level and gained access to vertebral body. Once the channel was created to intended target, the probe was opened from its box and placed in the channel to appropriate ablation zone. The physician elected for a 15 minute ablation and the ablation began. Physician began marking L5 incision point with a skin marker when the patient began moving. Anesthesia issues began to arise again and physician stopped marking to ensure patient was not moving. Six minutes after the ablation of S1 started, anesthetists said that the procedure needed to be aborted and the patient needed to be flipped again. Ablation was paused and entire cannula was removed at once. Patient was flipped back onto the bed and stabilized. Procedure was aborted and patient was taken to Post Anesthesia Care Unit (PACU). Per physician

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854527 ↗
• InjurySep 21, 2026Material Integrity Problem

  It was reported that during a Basivertebral Nerve (BVN) Radiofrequency Ablation (RFA) procedure, the Intracept tip fractured and a portion of the tip remained within the L4 vertebral body. The physician elected to leave the retained fragment in place.

  Patient problems: Foreign Body In Patient

  MAUDE report 50847122 ↗
• InjurySep 21, 2026Material Integrity Problem

  Patient problems: Foreign Body In Patient

  MAUDE report 50846962 ↗
• InjurySep 9, 2026Material Integrity Problem

  It was reported that during a basivertebral nerve (BVN) radiofrequency ablation (RFA) procedure, the bevel introducer cannula fractured while being advanced into the first vertebral body. The physician was malleting the introducer cannula when the clip on the bevel introducer cannula broke. It is unknown whether any fragmented material remained within the patient or if it was contained within the vertebral body. An additional device was used to complete the procedure. The patient is doing well, and no adverse effects were reported. The device is expected to be returned for analysis.Additional information was received stating that the fractured component was completely removed. The fracture was located at the top of the T handle body. No fragmented material remained within the patient.

  Patient problems: Foreign Body In Patient

  MAUDE report 50697506 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that abasivertebral nerve (BVN) radiofrequency ablation (RFA) procedure was performed successfully regards to patient pain. However, the patient developed a localized reaction at each incision site, characterized by severe itching. Minimal drainage was initially observed but subsequently resolved. The sites do not appear to be infected; however, laboratory testing has been ordered for further evaluation. Despite treatment with multiple medications and topical ointments, the patient continues to experience significant itching at the incision sites. The device will not be returned, as it was disposed of by the facility.

  Patient problems: Itching Sensation

  MAUDE report 50691017 ↗
• MalfunctionAug 4, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136064 ↗
• MalfunctionJun 1, 2026Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT DURING A BASIVERTEBRAL NERVE RADIOFREQUENCY ABLATION (BVN ABLATION) PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE J-STYLET. CONTINUED MALLETING RESULTED IN THE J-STYLET AND SURROUNDING PEEK COMPONENT FRACTURING AND BECOMING RETAINED WITHIN THE PATIENTS S1 VERTEBRA. THE PATIENT WAS RECOVERING POSTOPERATIVELY, AND UPON FOLLOW-UP, NO FURTHER ACTION WAS REQUIRED. THE DEVICE WILL NOT BE RETURNED, AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25355279 ↗
• InjuryMay 4, 2026Material Fragmentation; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE, THE PROCEDURE WENT AS PLANNED UNTIL THE REMOVAL OF THE CURVED CANNULA AT THE END OF THE PROCEDURE. THE CURVED CANNULA BECAME HOOKED ON HARD BONE IN THE VERTEBRAL BODY AND STRETCHED WHEN PULLING OUT. DURING TROUBLESHOOTING ATTEMPTS TO REMOVE THE CANNULA, IT FRACTURED. A SECOND PHYSICIAN WAS CALLED IN TO PERFORM AN ADDITIONAL DISSECTION DOWN TO THE PEDICLE TO ACCESS AND REMOVE THE PEEK COMPONENT. A PORTION OF THE PEEK MATERIAL REMAINS WITHIN THE BONE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075682 ↗
• MalfunctionApr 3, 2026Material Fragmentation; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT A CURVED CANNULA WAS RETURNED FOR AN UNKNOWN REASON AND VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA SHAFT TIP WAS BROKEN. THE J- STYLET WAS TESTED WITH A KNOWN GOOD CURVED CANNULA AND INTRODUCER CANNULA AND REVEALED THAT IT LACKS ANY EXTREME RESISTANCE AND LOCKED DURING THE FUNCTIONAL TEST. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. ADDITIONALLY, THE IFU STATES THAT AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION MUST BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENTS OR PROBE. EXCESSIVE FORCE CAN RESULT IN PRODUCT FAILURE. IT ALSO STATES THAT IN THE EVENT OF INADVERTENT ADVANCEMENT OF THE INTRODUCER CANNULA DURING DEPLOYMENT OF THE CURVED CANNULA ASSEMBLY, CARE MUST BE TAKEN TO PREVENT POTENTIAL FURTHER DEVICE DAMAGE. THIS CAN OCCUR IF MALLET STRIKES CONTINUE TO BE DELIVERED WHEN THE GEAR WHEEL IS IN CONTACT WITH THE INTRODUCER CANNULA. THIS SCENARIO CAN CREATE A CONDITION IN WHICH THE INTRODUCER CANNULA ADVANCES ALONG ITS STRAIGHT TRAJECTORY, WHILE THE CURVED CANNULA IS HELD IN THE BONE ALONG ITS CURVED TRAJECTORY. THIS CAN LEAD TO THE CREATION OF A KINK I

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780604 ↗
• InjuryMar 18, 2026Nonstandard Device

  DEVICE ANALYSIS PERFORMED ON THE RETURNED CURVED CANNULA1 CONFIRMED THAT THE SHAFT TIP WAS SHEARED. THE DAMAGE OBSERVED IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE DURING THE PROCEDURE. WITH THE AVAILABLE INFORMATION, TECHNICIANS ASSESSED THIS EVENT IS ATTRIBUTED TO AN UNINTENDED USE ERROR. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AND STATES THAT WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION MUST BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENTS OR PROBE. EXCESSIVE FORCE CAN RESULT IN PRODUCT FAILURE. LABELING ALSO STATES THAT IN THE EVENT OF INADVERTENT ADVANCEMENT OF THE INTRODUCER CANNULA DURING DEPLOYMENT OF THE CURVED CANNULA ASSEMBLY, CARE MUST BE TAKEN TO PREVENT POTENTIAL FURTHER DEVICE DAMAGE. THIS CAN OCCUR IF MALLET STRIKES CONTINUE TO BE DELIVERED WHEN THE GEAR WHEEL IS IN CONTACT WITH THE INTRODUCER CANNULA. THIS SCENARIO CAN CREATE A CONDITION IN WHICH THE INTRODUCER CANNULA ADVANCES ALONG ITS STRAIGHT TRAJECTORY, WHILE THE CURVED CANNULA IS HELD IN THE BONE ALONG ITS CURVED TRAJECTORY. THIS CAN LEAD TO THE CREATION OF A KINK IN THE CURVED CANNULA MATERIAL. IF IT IS SUSPECTED THAT THIS OCCURRED, OR IF RETRACTION OF THE CURV

  Patient problems: Foreign Body In Patient

  MAUDE report 24634829 ↗
• MalfunctionJan 13, 2026Material Fragmentation; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THERE WAS TENSION WHEN THE PHYSICIAN PLACED THE J-STYLET IN THE CORRECT POSITION. WHEN THE CURVED CANNULA ASSEMBLY WAS REMOVED, THE PEEK WAS MISSING. THIS HAPPENED TO BOTH CURVED CANNULAS IN THE SAME KIT. IT WAS NOTED THAT THERE WAS PEEK OVERDRIVE WHERE THE PEEK BECAME RIGID AND TORN AFTER ONE LEVEL WAS COMPLETED. A BIT OF THE PEEK WAS BROKEN OFF WHEN THE PHYSICIAN TRIED TO WHEEL UP THE J-STYLET INTO THE CURVED CANNULA ASSEMBLY AND IT WAS LEFT INSIDE THE PATIENT. IT IS UNKNOWN IF THE DEVICE FRAGMENT WAS CONTAINED INSIDE OR OUTSIDE THE BONE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24063777 ↗