HALO 72290134Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00885556699928), received between Jun 3, 2020 and May 31, 2026 — classified as 1 death, 40 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Flaked

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY PROCEDURE, A PART OF THE BLACK PLASTIC SHEATH OF THE COBLATION HALO WAND HAD BECOME ERODED EXPOSING UNDERNEATH ACTIVE ELECTRODE, WHICH LEFT AN ABRASION ON PATIENT LIP. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. PATIENT WAS SENT HOME WITH VASOLINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 25345331 ↗
• MalfunctionMay 18, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem; Scratched Material

  IT WAS REPORTED THAT, AFTER AN ADENOIDECTOMY AND TONSILLECTOMY IN WHICH A HALO COBLATION WAND WAS USED, IT WAS NOTICED THAT THE PATIENT HAD SUPERFICIAL BURNS IN BOTH THE LEFT AND RIGHT SIDE OF THEIR FACE AND THE WAND HAD A SMALL DEFECT IN THE INSULATION, IT HAD SCRATCH ON THE SIDE. THE SETTING USED ON THE CONTROLLER WAS HI DEFAULT COAG ON 3 DOTS AND SALINE ON 5 DROPS. THE ACTIVATION TIME FOR THE WAND WAS LESS THAN 30 MINUTES. THE WAND WAS NOT BRUSHED AGAINST ANY INSTRUMENT. THE PATIENT WAS TREATED WITH AN OINTMENT AND HAS RECOVERED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 25211769 ↗
• MalfunctionApr 28, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE, A SURGEON EXPERIENCED AN ISSUE WITH THE HALO WAND. THE PROBE WAS BEING USED WITH A WEREWOLF GENERATOR (IRRIGATION SET TO 4, ABLATION SET TO HI, AND HEMOSTASIS SET TO 1).THE WAND EXHIBITED ABNORMAL BEHAVIOR, WITH EXCESSIVE SMOKE EMISSION ACCOMPANIED BY A RISE IN TEMPERATURE. THE PROBES WAS NOT INTRODUCED INTO THE PATIENT¿S MOUTH, AS THE ISSUE WAS IDENTIFIED BEFOREHAND. THEREFORE, IT DID NOT SEEM TO BE RELATED TO SUCTION BLOCKAGE OR TISSUE RESIDUE CAUSING OVERHEATING AT THE ELECTRODE. THE PROCEDURE WAS PERFORMED, USING AN EQUIVALENT SN BACKUP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024231 ↗
• MalfunctionJan 7, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING A PROCEDURE, THE COBLATION HALO WAND RUBBER SHAFT PEELED BACK, EXPOSING WHAT LAY BENEATH. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989125 ↗
• MalfunctionDec 17, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, AFTER AN ADENOTONSILLECTOMY SURGERY, IT WAS NOTICED THAT PART OF THE COBLATION HALO WAND'S INSULATION HAD RUBBED AWAY AND THERE WAS A SMALL SUPERFICIAL INJURY TO THE PATIENT'S LIP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23827404 ↗
• MalfunctionDec 15, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY PROCEDURE, THE COBLATION HALO WAND WAS NOT ABLATING AT ALL, EVEN THOUGH SALINE DELIVERY WAS APPLIED. THE PROCEDURE WAS RESUMED, WITH A DELAY GREATER THAN 30 MINUTES, USING A SIMILAR S+N BACK-UP. THE PATIENT WAS EXPOSED TO FURTHER ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804563 ↗
• MalfunctionDec 2, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY/ ADENOIDS SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A BURN ON THE OUTER CHEEK AND WHEN LOOKING AT THE WAND, THERE WAS A NOTICEABLE FLAW ALONG THE SHAFT THAT COULD HAVE COME INTO CONTACT WITH PATIENT. THE PATIENT AS OF NOW IS OK, JUST THE BURN RIGHT OUTSIDE OF THE MOUTH.

  Patient problems: Burn(s); Localized Skin Lesion

  MAUDE report 23700864 ↗
• MalfunctionOct 30, 2025Crack; Material Integrity Problem; Scratched Material; Crack; Material Integrity Problem; Scratched Material

  IT WAS REPORTED THAT, BEFORE A ADENOIDECTOMY , IT WAS NOTICED THAT ONE (1) COBLATION HALO WAND HAD SOME CRACKS ON THE MIDDLE OF IT AND THE METAL PLATE INSIDE THE SHAFT WAS EXPOSED. THE PROCEDURE WAS PERFORMED AFTER A 5 MINUTES DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425534 ↗
• MalfunctionOct 28, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE COBLATION HALO WAND'S BLACK RUBBER PART RIPPED OFF THE SHAFT, EXPOSING A TINY PIECE OF THE UNDERLYING ELECTRODE, WHICH CAUSED A BURN TO THE INSIDE OF THE PATIENT'S MOUTH. HOWEVER, THE ISSUE WITH THE DEVICE WAS NOTED AFTER THE PROCEDURE. THE PROCEDURE WAS RESUMED, THERE WAS A DELAY OF LESS THAN 30 MINUTES, USING THE SAME REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 23408093 ↗
• MalfunctionOct 28, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, THE BENDING TOOL WAS USED TO BEND ONE (1) COBLATION HALO WAND, AND IT CAUSED THE INSULATION OF THE DEVICE TO TEAR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407436 ↗
• MalfunctionSep 4, 2025Suction Problem; Activation Failure; Suction Problem; Activation Failure

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE COBLATION HALO WAND WAS NOT ABLATING PROPERLY. IT LOOK LIKE IT WAS CAUTERIZING THE TISSUE. THE TISSUE WAS ¿CHARRED¿ AND KEPT BLOCKING THE SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964003 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, IN WHICH A HALO COBLATION WAND WAS USED, THE PATIENT EXPERIENCED SIGNIFICANT INTRAOPERATIVE BLEED, LOSING AN ESTIMATED OF 400-500 ML OF BLOOD. THE BLEEDING WAS TREATED BY PACKING, BIPOLAR FORCEPS AND INTERVENTIONAL RADIOLOGY PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED, AND THEN, THE PATIENT WAS TRANSFERRED TO TERTIARY HOSPITAL FOR FURTHER EVALUATION AND OBSERVATION. AFTER A PERIOD OF OBSERVATION, THE PATIENT HAS BEEN DISCHARGED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22810478 ↗
• InjuryAug 13, 2025Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE COBLATION HALO WAND PRESENTED INTERMITTENT INCISIONS. THE ELECTRODE WAS NOT PERFORMING ABLATION. THE DEVICE WAS DISCONNECTED AND RECONNECTED, BUT THE PROBLEM CONTINUED, AND THE SPECIALIST APPLIED SLIGHTLY MORE FORCE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. AT THE END OF THE PROCEDURE, THERE WAS A HEMATOMA IN THE RIGHT CAVITY, WHICH WAS THE FIRST TONSIL REMOVED WITH THE FAULTY DEVICE, AND A HOLE THAT REQUIRED TWO STITCHES. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 22795382 ↗
• MalfunctionAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN ENT SURGERY WITH A COBLATION HALO WAND WITH HIGH DOT SETTINGS, A PRIMARY BLEEDING OCCURRED AT THE INFERIOR POLE OF THE TONSIL BED. THE PATIENT LOST 400-600 ML OF BLOOD. THE BLEEDING WAS IMMEDIATELY TREATED WITH BIPOLAR FORCEPS AND PACKING, BUT THEN TRANSFERRED TO ANOTHER FACILITY FOR SCANS AND IR TREATMENT WITH COIL. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22710131 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY, USING A HALO WAND, THE PATIENT RETURNED RE-BLEEDING 24 HOURS LATER, AND HAD SURGICAL INTERVENTION. AS A RESULT OF THE SURGICAL INTERVENTION, THE BLEEDING STOPPED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22666594 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE WEEK AFTER A TONSILLECTOMY IN WHICH A HALO WAND WAS USED, THE PATIENT EXPERIENCED RE-BLEEDING AND WAS BROUGHT BACK TO THE HOSPITAL FOR SURGICAL INTERVENTION. THE BLEEDING WAS TREATED WITH SUCTION CAUTERY SUCCESSFULLY STOPPED. THE PATIENT WAS DEHYDRATED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22627857 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE WEEK AFTER A TONSILLECTOMY IN WHICH A HALO WAND WAS USED, THE PATIENT EXPERIENCED RE-BLEEDING, WHICH WAS MEDICALLY TREATED AT THE ER WITH TXA MEDICATION. NO SURGICAL INTERVENTION WAS REQUIRED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22552880 ↗
• MalfunctionApr 15, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING A T&A PROCEDURE, THE COBLATION HALO WAND WAS EXCESSIVELY HOT AND SMOKING. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. THERE WAS NO DAMAGE/BURN CAUSED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840423 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE WHERE A COBLATION HALO WAND WAS USED, THE PATIENT AND HIS PARENTS APPRECIATED A HOLE IN THE RIGHT POSTERIOR TONSILLAR PILLAR THAT COLLECTED FOOD PARTICLES. AN UNKNOWN INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF THE ISSUE WAS TREATED OR THE PATIENT'S STATUS.

  Patient problems: Perforation

  MAUDE report 20326694 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT DURING SET UP, AFTER THE COBLATION HALO WAND WAS BENT WITH THE COBLATOR BENDING TOOL, THE INSULATOR ON THE SHAFT OF THE WAND SEEMED TO BREAK OR BE EXPOSED. THERE WAS A BACKUP DEVICE AVAILABLE AND THERE WAS A DELAY OF LESS THAN 30 MINUTES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272966 ↗
• MalfunctionSep 16, 2024Failure to Conduct; Activation Failure; Failure to Conduct; Activation Failure

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE COBLATION HALO WAND WAS NOT CUTTING, AND THEN A SCREEN POPPED UP THAT SAID THAT THE WAND HAD REACHED END OF LIFE. THE PATIENT WAS ANESTHETIZED WHEN THE PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224211 ↗
• MalfunctionAug 20, 2024Overheating of Device; Unexpected Shutdown; Overheating of Device; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE COBLATION HALO WAND STARTED TO HEAT UP AND STOPPED COAGULATING AFTER BEING USED IN ONE SIDE OF THE TONSIL. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001596 ↗
• MalfunctionAug 9, 2024Peeled/Delaminated; Insufficient Device Problem Information; Peeled/Delaminated; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER AN ADENOIDECTOMY PROCEDURE, THE PATIENT LIP WAS BURNT ON THE CORNER WHERE THE COBLATION HALO WAND HAS BEEN LAYING ON THE LIP. THE WAND WAS INSPECTED, IT APPEARS AS THE CASING HAVE BEEN COMPROMISED AND THE METAL UNDERNEATH SEEMS TO HAVE BLANCHED THE PATIENT¿S LIP. THE BURN ON THE LIP WAS WHITE AND 1ST DEGREE, VASELINE WAS APPLIED ON THE BURN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19951474 ↗
• DeathAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NINE DAYS AFTER A TONSILLECTOMY USING A COBLATION HALO WAND, THE PATIENT HAD A MEDICAL INCIDENT AND PASSED AWAY. THE CAUSE OR FURTHER INFORMATION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19913312 ↗
• InjuryAug 5, 2024Melted; Melted

  IT WAS REPORTED THAT DURING A BILATERAL MYRINGOTOMY WITH ADENOIDECTOMY PROCEDURE, THE BLACK SHAFT OF THE COBLATION HALO WAND MELTED AND BURNED THE INSIDE OF THE PATIENT'S MOUTH AND LIP, CAUSING A SUPERFICIAL MUCOSAL ABRASION THAT WAS TREATED WITH BACITRACIN IN THE OR SUITE. THE WAND WAS ACTIVATED FOR APPROXIMATELY 10 MINUTES AND THE LIP WAS NOT PROTECTED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED HOME THE SAME DAY.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 19913311 ↗