Cavitron® 80799Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI D003807991), received between Jul 18, 2023 and Feb 6, 2026 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “No Flow” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026No Flow

  IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-1000 INSERT PACKED IS ALLEGED THAT THERE IS NO WATER COMING THROUGH THE TIPS. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277659 ↗
• MalfunctionJan 23, 2026Break

  IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-1000 INSERT, PACKED ALLEGED THE TIP BROKE DURING USE IN PATIENT'S MOUTH. ATTEMPTED TO RETRIEVE THE BROKEN PART FROM PATIENT BUT PATIENT BEGAN TO SWALLOW AND TONGUE MOVEMENT CAUSED MOVEMENT OF BROKEN TIP. SUCTION WAS PLACED IN THE AREA WHERE THE TIP WAS BROKEN. UNSURE IF PATIENT SWALLOWED TIP OR IF TIP GOT SUCTIONED. PATIENT REPORTED NO TROUBLE BREATHING OR SWALLOWING. A PANORAMIC RADIOGRAPH SHOWED NO EVIDENCE OF BROKEN TIP IN PATIENT'S MOUTH. PATIENT WAS DIRECTED TO PROCEED TO ED FOR IMAGING TO CONFIRM IF BROKEN TIP HAD NOT BEEN ASPIRATED OR INGESTED. PATIENT WAS EVALUATED, CHEST AND ABDOMINAL RADIOGRAPHS REVIEWED AND NO IDENTIFIABLE FOREIGN BODY WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161861 ↗
• MalfunctionAug 22, 2025Overheating of Device; No Flow; Overheating of Device; No Flow

  IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-1000 INSERT,PACKED IS ALLEGED THAT NO WATER COMING THROUGH AND GETTING HOT. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879476 ↗
• MalfunctionJul 16, 2025Overheating of Device; Overheating of Device

  IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-1000 INSERT,PACKED ALLEGEDLY THE TIP OF THE INSERT IS BLACK, THAT IT MIGHT HAVE BURNED. THE INSERT OVERHEATED. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521608 ↗
• MalfunctionMay 1, 2025No Flow; No Flow

  IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-1000 INSERT,PACKED ALLEGEDLY HAD NO WATER AND THE INSERT WAS GETTING HOT. REPORTEDLY, NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944426 ↗
• MalfunctionJan 22, 2025Break; Break

  IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-1000 INSERT,PACKED TIP BROKE DURING USE. REPORTEDLY, THE TIP COULD NOT BE LOCATED AND THE PATIENT WAS SENT TO A&E. THERE IS NO FOLLOW UP ON THE PATIENT. THE OUTCOME IS UNKNOWN AS OF THIS MDR.

  Patient problems: Insufficient Information

  MAUDE report 21208838 ↗
• DeathFeb 14, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT INVOLVED IN THIS INCIDENT DIED DUE TO CARDIAC ARREST. THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT DIED ON (B)(6) 2024. THE SPOUSE REPORTED THAT THE PATIENT HAD COMPLICATIONS FROM THE SURGERY TO REMOVE THE BROKEN PIECE OF THE DEVICE THAT WAS INGESTED AND WAS IN AND OUT OF THE HOSPITAL MANY TIMES SINCE THE SURGERY. THE SPOUSE ALLEGES, "I CANNOT BEGIN TO EXPRESS TO YOU THE EXTREME PAIN AND STRESS THIS HAS CAUSED HIM, SO MUCH TO THE POINT HE COULDN¿T TAKE IT ANY LONGER.¿

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18707578 ↗
• MalfunctionSep 14, 2023Overheating of Device; No Flow; Overheating of Device; No Flow

  IN THIS EVENT IT IS REPORTED THAT 30K FSI-PWR-1000 INSERT,PACKED WATER IS NOT FLOWING THROUGH AND THE TIP OVERHEATS. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745544 ↗
• MalfunctionJul 18, 2023Overheating of Device; Overheating of Device

  IN THIS EVENT IT IS REPORTED THAT 30K FSI-PWR-1000 INSERT,PACKED GET HOT DURING USE. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341602 ↗