BAROSTIM NEORecalls & reported problems across all models

We found 2 models of BAROSTIM NEO by Cvrx, Inc. in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between Jul 15, 2021 and Sep 17, 2026 — classified as 1 death, 101 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BAROSTIM NEO problems

BAROSTIM NEO models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BAROSTIM NEO 1036

  Stimulator, Carotid Sinus Nerve
  1 death78 reports
• BAROSTIM NEO 2102

  Stimulator, Carotid Sinus Nerve
  24 reports

Recent BAROSTIM NEO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Material Twisted/Bent

  Patient problems: Pain; Twiddlers Syndrome

  MAUDE report 50805739 ↗
• InjurySep 14, 2026Unintended Movement

  A Barostim system was implanted on (b)(6) 2025 and last titrated on (b)(6) 2025 where therapy amplitude was increased from 6.4mA to 7.0mA. Around (b)(6) 2025, the patient experienced extraneous stimulation in the form of tightness on the right side of their neck which worsened around (b)(6) 2026. The patient was seen for a follow up on (b)(6) 2026 and they were able to replicate the stim by raising their right arm. The patient's therapy was reduced to 5.0mA and the stim resolved. On a later date, the patient continued to experience tightness in their throat. On (b)(6) 2026, the patient's therapy was adjusted to 4.2mA. Labs were ordered as the clinicians believed that the patient's CHF may have worsened. The patient continued to experience issues with stim near their throat and imaging was done. The electrode and the positioning of the device looked good, however the excess lead in the pocket appeared to have migrated underneath the bottom of the IPG which potentially caused a pulling like sensation on the lead. Per the opinion of the physician, the root cause of the migration was possibly due to the patient's bariatric surgery which caused a lot of excess skin and potentially cause

  Patient problems: Neck Pain; Undesired Nerve Stimulation

  MAUDE report 50753367 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain; Twiddlers Syndrome

  MAUDE report 50571111 ↗
• InjuryAug 24, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420610 ↗
• InjuryAug 12, 2026Use of Device Problem

  A Barostim system was implanted on (b)(6) 2025. On (b)(6) 2026, impedance was low, and Barostim therapy was turned off. It was noted the system passed compliance as of the last Barostim check on (b)(6) 2026, but the lead impedance had decreased significantly from approximately 850 to 150 Ohms on approximately (b)(6) 2026 and decreased to low around (b)(6) 2026. There were no unusual events or physical stresses on the system reported by the patient, and the patient did not report any symptoms or adverse events. A chest and neck x-ray were ordered and showed the lead completely detached from the IPG header. In the opinion of the physician, the root cause of the lead detachment could not be conclusively determined, but Twiddler Syndrome was possible as the patient reported frequent touching of their IPG pocket. A successful lead revision occurred on 16-Jul-2026. The old lead was extracted, and a new lead was placed on the same carotid artery with a good BP response.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223996 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Skin Discoloration

  MAUDE report 50213807 ↗
• InjuryJun 24, 2026Material Twisted/Bent

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. AROUND (B)(6) 2026, THE PATIENT EXPERIENCED MOVEMENT WITH THEIR IPG. AN X-RAY WAS DONE. PER THE PHYSICIAN, THE ROOT CAUSE OF THE EVENT WAS THAT THE PATIENT WAS ROTATING THE DEVICE IN THE POCKET. ON (B)(6) 2026, A SUCCESSFUL POCKET REVISION WAS DONE. THE LEAD WAS STRAIGHTENED AND THE DEVICE WAS SECURED IN THE MEDIAL POCKET. IT WAS NOTED THAT THE LEAD AND IMPEDANCE WERE TESTED AND WERE BOTH WITHIN NORMAL RANGE.

  Patient problems: Twiddlers Syndrome

  MAUDE report 25610246 ↗
• InjuryMay 27, 2026Appropriate Device Problem Term/Code Not Available

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2024 AND LAST TITRATED ON (B)(6) 2024 WHERE THERAPY WAS INCREASED FROM 7.4MA TO 9.0MA. AROUND (B)(6) 2025, THE PATIENT EXPERIENCED PULLING IN THEIR NECK. THE SURGEON NOTED THAT AFTER PALPATING THE LEAD, IT FELT "AS TIGHT AS A GUITAR STRING". AROUND (B)(6) 2026, THE PATIENT HAD A CT DONE. THE CT OF THE CHEST WAS DONE IN A SUPINE POSITION, AND THE LEAD APPEARED TO HAVE SLACK. ADDITIONAL IMAGING WAS BEING DONE, HOWEVER WAS NOT YET AVAILABLE. A SUGGESTION WAS MADE TO ADJUST THE PATIENT'S THERAPY TO RULE OUT STIMULATION. THE SURGEON WAS WORKING WITH THE CARDIOLOGIST TO SCHEDULE THE PATIENT FOR A LEAD REVISION. IT WAS NOTED THAT THE PATIENT HAD A POOR PROGNOSIS DUE TO CANCER DIAGNOSIS AND CHOSE TO HAVE THE DEVICE EXPLANTED AND THEY NEEDED TO PUT A PORT IN AS THEY WERE UNDERGOING CHEMO. PER THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE EVENT WAS POSSIBLY DUE TO RADIATION THERAPY ON THE LEAD. THE DEVICE WAS EXPLANTED ON (B)(6) 2026.

  Patient problems: Discomfort

  MAUDE report 25311580 ↗
• InjuryMay 27, 2026Material Twisted/Bent

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH, SWELLING AND ABDOMINAL PAIN AND AN X-RAY WAS DONE ROUTINELY AND SHOWED THE IPG PROJECTING OVER THEIR RIGHT UPPER CHEST, EXTENDING INTO THE RIGHT NECK, WITH SEVERAL TWISTS AND TURNS ALONG THE PATH OF THE LEAD. AROUND 30-MAR-2026, THE PATIENT EXPERIENCED TIGHTNESS IN THEIR NECK WHEN THEY TURN THEIR HEAD TO THE RIGHT AND ON (B)(6) 2026, THEY HAD A VIRTUAL FOLLOW UP WITH THEIR PHYSICIAN. IT WAS SUSPECTED THAT THE ROOT CAUSE WAS TWIDDLERS SYNDROME DUE TO TWISTING AND TURNING OF THE BATTERY/GENERATOR IN ITS POCKET. AN X RAY WAS DONE, REVEALING A TWIST IN THE LEAD. IT WAS NOTED THAT THE LEAD DID NOT APPEAR FRACTURED AND THEY WERE UNSURE IF THE DEVICE WAS WORKING. THE PATIENT WAS SEEN FOR A FOLLOW UP ON (B)(6) 2026 AND THEIR LEAD IMPEDANCE WAS AT 130. ON (B)(6) 2026, A SUCCESSFUL LEAD REVISION WAS DONE. THE FRACTURED LEAD WAS CUT, AND A NEW LEAD WAS PLACED TO THE LEFT CAROTID. PER THE OPINION OF THE PHYSICIAN, IT WAS SUSPECTED THAT THAT THE SOB MAY HAVE BEEN CAUSED BY BAROSTIM NOT DELIVERING THE THERAPY APPROPRIATELY, AND AS OF (B)(6) 2026, THE PATIENT REPOR

  Patient problems: Discomfort; Dyspnea; Swelling/ Edema; Twiddlers Syndrome

  MAUDE report 25306882 ↗
• InjuryMay 27, 2026Material Twisted/Bent

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2024. THE PATIENT WAS SEEN FOR A DEVICE INTERROGATION ON (B)(6) 2026, AND IT WAS DISCOVERED THAT AROUND ON (B)(6) 2025 THE SYSTEM WAS OUT OF COMPLIANCE AND THE LEAD IMPEDANCE WAS HIGH. IT WAS NOTED THAT THE PATIENT HAD A CHIROPRACTIC ADJUSTMENT THAT CORRESPONDED WITH THE DATE OF THE IMPEDANCE CHANGE. AN X-RAY WAS ORDERED AND THE PATIENT'S THERAPY WAS DEACTIVATED. PER THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE EVENT WAS THAT THE CSL MIGRATED INTO SUBCUTANEOUS MUSCLE HOWEVER, PER THE X-RAY'S, IT LOOKED LIKE THE ELECTRODE WAS SEPARATING FROM THE LEAD BODY. THEY WERE SCHEDULED FOR A FOLLOW-UP ON (B)(6) 2026, HOWEVER AS OF ON (B)(6) 2026, THERE WERE NO ADDITIONAL UPDATES PROVIDED. IT WAS NOTED THAT THE SURGEON'S OFFICE WAS GOING THROUGH A TRANSITION AND WAS UNRESPONSIVE ON ALL ISSUES. ON (B)(6) 2026, THE PATIENT'S DEVICE WAS EXPLANTED SUCCESSFULLY AND SENT TO PATHOLOGY. AN ATTEMPT WAS MADE TO RETRIEVE THE EXPLANTED DEVICE BUT WAS UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306819 ↗
• InjuryMay 27, 2026Material Twisted/Bent

  NEBRASKA LOW IMPEDANCE- A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2025. AROUND (B)(6) 2026, THE PATIENT EXPERIENCED AN INTERMITTENT GURGLING SENSATION AT THE IPG LOCATION. THE PATIENT DENIED MANIPULATING THE DEVICE OR EXPERIENCING ANY TRAUMA THAT MIGHT HAVE IMPACTED THE DEVICE. THEY REPORTED THAT WHEN SLEEPING AT NIGHT, THE DEVICE "POKED OUT". WHILE REVIEWING THE IMPEDANCE TREND, IT WAS NOTED THAT THERE WAS A STEEP DIP IN IMPEDANCE THAT CORRELATED WITH THE DAY THE PATIENT BEGAN TO EXPERIENCE SYMPTOMS. THE GURGLING SENSATION AND LOW IMPEDANCE OF 330 WAS REPLICABLE WHILE THE PATIENT WAS MOVING AROUND. WHEN THE PATIENT WAS SEATED THE IMPEDANCE WENT BACK TO 803. THE PATIENT'S THERAPY WAS REDUCED TO 5MA AND XRAY WAS ORDERED AND REVEALED TWISTS IN THE LEAD. A LEAD AND POCKET REVISION OCCURRED ON (B)(6) 2026. A NEW LEAD WAS IMPLANTED, AND THE DEVICE WAS SECURED IN THE POCKET. AS OF (B)(6) 2026, THE PATIENT'S SYMPTOMS WERE RESOLVED AND THE IMPEDANCE WAS NORMAL.

  Patient problems: Twiddlers Syndrome; Undesired Nerve Stimulation

  MAUDE report 25300149 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS AND A SWOLLEN TONGUE AND ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT. A STROKE WAS RULED OUT AT THE ED, AND THE PATIENT WAS SENT HOME. ON (B)(6) 2026 AT A SCHEDULED TITRATION FOLLOW-UP, THE PATIENT REPORTED THAT THEY EXPERIENCED A SWOLLEN TONGUE, TONGUE DEVIATION, DIFFICULTY SWALLOWING AND SPEAKING, RIGHT LEG SPASMS, INTERMITTENT HEADACHES, PINS AND NEEDLES SENSATION ON THE RIGHT SIDE OF THEIR FACE AND NECK, NUMBNESS ON THE RIGHT SIDE OF THEIR FACE AND NECK, A TEARY RIGHT EYE AND BLURRY VISION IN THEIR RIGHT EYE. PER THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE TONGUE MOVEMENT ISSUES WAS LIKELY CAUSED BY BAROSTIM DUE TO THE PROXIMITY OF THE HYPOGLOSSAL NERVE, HOWEVER, WAS UNSURE IF THE OTHER ISSUES WERE BEING CAUSED OR CONTRIBUTED TO BY BAROSTIM. THE PHYSICIAN OBSERVED A HARD LUMP UNDER THE INCISION, AT THE SITE OF THE ELECTRODE AND HYPOTHESIZED THAT IT MIGHT BE CAUSING PRESSURE ON OTHER SURROUNDING NERVES TO CREATE THESE OTHER EXTRANEOUS COMPLAINTS. THE PATIENT'S BAROSTIM THERAPY WAS TURNED OFF TO ALLOW MORE TIME FOR HEALING, AND IT WAS NOTED THAT

  Patient problems: Excessive Tear Production; Headache; Nerve Damage; Numbness; Swelling/ Edema

  MAUDE report 25218548 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. ON (B)(6) 2026, FOLLOWING A LONG DAY OF INCREASED ACTIVITY, THE PATIENT EXPERIENCED REDNESS, TENDERNESS, WARMTH AND SWELLING NEAR AND ABOVE THE CHEST INCISION AS WELL AS CHEST DISCOMFORT. ON (B)(6) 2026 THEY PRESENTED TO THE EMERGENCY ROOM WHERE THEY WERE ADMITTED. LABS AND AN EKG WERE DONE AND INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED. IT WAS REPORTED THAT CELLULITIS WAS FOUND ON THE LEAD ATTACHED TO THE RIGHT CAROTID AND ON (B)(6) 2026, THE LEAD WAS EXPLANTED. PER THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE INFECTION WAS UNKNOWN. THE PATIENT WAS DISCHARGED ON (B)(6) 2026, THE INFECTION RESOLVED.

  Patient problems: Bacterial Infection; Discomfort; Swelling/ Edema

  MAUDE report 25218238 ↗
• InjuryApr 25, 2026Material Twisted/Bent; Unintended Movement

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2025. AROUND ON (B)(6) 2026, THE PATIENT'S LEAD IMPEDANCE DECREASED RAPIDLY. IT WAS NOTED THAT AROUND THAT TIME, THE DEVICE TURNED WHILE THE PATIENT WAS WAKING UP AND THE PATIENT MANUALLY TURNED IT BACK. THE DEVICE WAS TESTED AND CONSTANTLY PASSED COMPLIANCE AND STIM WAS EXPERIENCED ONCE. THERAPY WAS STILL BEING DELIVERED, HOWEVER THE PATIENT REPORTED BEING MORE TIRED IN A TIMEFRAME THAT COINCIDES WITH THE IMPEDANCE DROP. AN X-RAY WAS ORDERED AND THE IMAGES REVEALED THAT THE IPG DROPPED INFERIOR TO THE CHEST WALL, AS WELL AS MULTIPLE COILS IN THE LEAD NEAR THE HEADER OF THE IPG. A LEAD REVISION OCCURRED ON (B)(6) 2026. THE DAMAGED LEAD AND THE IPG WERE EXPLANTED AND A NEW GENERATOR AND LEAD WERE IMPLANTED.

  Patient problems: Fatigue; Twiddlers Syndrome; Undesired Nerve Stimulation

  MAUDE report 24991398 ↗
• InjuryApr 21, 2026Loss of or Failure to Bond

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. DURING A NORMAL IPG REPLACEMENT ON (B)(6) 2026, HIGH IMPEDANCE WAS NOTICED. THE CSL WAS REMOVED FROM THE IPG, AND THE CSL PIN HAD PULLED OUT FROM THE RING. IT WAS UNKNOWN IF THE PHYSICIAN HAD FULLY LOOSENED BOTH SET SCREWS AS THEY WERE MOVING FAST, BUT THE PHYSICIAN STATED THEY THOUGHT THERE WAS A DEFECT IN THE CONNECTION. THE CSL WAS CAPPED, AND NO NEW IPG WAS IMPLANTED. THE PROCEDURE WAS NOT DELAYED BY GREATER THAN 30 MINUTES DUE TO THE ISSUE, AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. A CSL EXPLANT AND BAROSTIM REIMPLANT OCCURRED ON (B)(6) 2026. A NEW IPG WAS PLACED, AND A NEW CSL PLACED ON THE OPPOSITE CAROTID. THE INITIAL CSL WAS LEFT IMPLANTED AND CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944530 ↗