Rapid Rhino RR 750Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00817470006636), received between Apr 11, 2019 and Oct 30, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, AFTER AN ENT PROCEDURE, WHEN THE SURGEON TRIED TO EXTRACT THE DEVICE OUT FROM THE PATIENT, TWO (2) RAPID RHINO'S AIR INFLATION TUBES CAME OFF, LEAVING THE BALLOON INSIDE THE PATIENT, THE SURGEON USED TOOTH FORCEPS TO PULL IT OUT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425408 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, AFTER AN ENT PROCEDURE, WHEN THE SURGEON TRIED TO EXTRACT THE DEVICE OUT FROM THE PATIENT, ONE (1) RAPID RHINO'S AIR INFLATION TUBES CAME OFF, LEAVING THE BALLOON INSIDE THE PATIENT, THE SURGEON USED TOOTH FORCEPS TO PULL IT OUT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407626 ↗
• MalfunctionApr 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, WHEN THE RAPID RHINO WAS REMOVED, IT TORE BETWEEN THE CUFF AND THE BALLOON. THE TORN TAMPONADE WAS REMOVED FROM THE PATIENT WITH FORCEPS. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21836328 ↗
• MalfunctionSep 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE RAPID RHINO'S CUFF WAS TORN OFF THE TAMPONADE WHEN REMOVING THE TAMPONADE. TWEEZERS HAD TO BE USED TO PULL IT OUT AND REMOVE THE TAMPONADE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236745 ↗
• MalfunctionJun 24, 2024Material Discolored; Detachment of Device or Device Component; Material Discolored; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON FOUND DISCOLORATION ON THE PACKAGE OF THE RAPID RHINO AND THOUGHT IT WAS JUST THE PACKAGING, AND USED THE PRODUCTS ON PATIENT. HOWEVER, AFTER AN ENT PROCEDURE, WHILE EXTRACTING OUT ONE PRODUCT FROM PATIENT THE NEXT DAY, THE RAPID RHINO AIR INFLATION TUBE CAME OFF, LEAVING THE BALLOON INSIDE PATIENT, THE SURGEON REQUESTED FOR A TOOTH FORCEPS TO PULL OUT THE BALLOON INSIDE THE PATIENT NOSTRIL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602678 ↗
• MalfunctionJun 18, 2024Material Discolored; Detachment of Device or Device Component; Material Discolored; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON FOUND DISCOLORATION ON THE PACKAGE OF THE RAPID RHINO AND THOUGHT IT WAS JUST THE PACKAGING, AND USED THE PRODUCTS ON PATIENT. HOWEVER, AFTER AN ENT PROCEDURE, WHILE EXTRACTING OUT ONE PRODUCT FROM PATIENT THE NEXT DAY, THE RAPID RHINO AIR INFLATION TUBE CAME OFF, LEAVING THE BALLOON INSIDE PATIENT. THE SURGEON REQUESTED FOR TOOTH FORCEPS TO PULL OUT THE RAPID RHINO BALLOON AFTER THAT. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563614 ↗
• MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN ENT PROCEDURE, THE RAPID RHINO SWALLOW GUARD PART DETACHED AND FELL OFF. THE DEVICE HAD TO BE EXTRACTED FROM PATIENT USING FORCEPS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131431 ↗
• MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN ENT PROCEDURE, THE RAPID RHINO SWALLOW GUARD PART DETACHED AND FELL OFF. THE DEVICE HAD TO BE EXTRACTED FROM PATIENT USING FORCEPS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130524 ↗
• MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN ENT PROCEDURE, THE RAPID RHINO SWALLOW GUARD PART DETACHED AND FELL OFF. THE DEVICE HAD TO BE EXTRACTED FROM PATIENT USING FORCEPS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130512 ↗
• MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN ENT PROCEDURE, THE RAPID RHINO SWALLOW GUARD PART DETACHED AND FELL OFF. THE DEVICE HAD TO BE EXTRACTED FROM PATIENT USING FORCEPS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130492 ↗
• InjuryAug 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN ENT PROCEDURE WITH RHINO ROCKETS PLACED IN BILATERAL NARES FOR STOPPING BLOOD FLOW FROM NOSE AFTER A FALL, PATIENT BECAME SICK AND STARTED VOMITING LARGE CLOTS AFTER 4 HOURS WITH THE RHINO ROCKETS. THE PHYSICIAN REMOVED RHINO ROCKET FROM NARES, BUT THE LEFT ONE WAS MISSING THE ABSORBABLE TAMPONADE OF THE DEVICE. IT HAD SOMEHOW DETACHED FROM THE BULB OF THE DEVICE. TAMPONADE WAS NOT FOUND ON THE PATIENT, IN PATIENT BED OR IN EMESIS OF PATIENT. X-RAYS OF THE ABDOMEN AND CHEST NEITHER SHOWED THE PIECE OF THE DEVICE ANYWHERE IN THE PATIENT. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY DUE TO HEAVY EPISTAXIS. PATIENT HAD A NOSEBLEED IN THE ER. CT OF FACE SHOWED BILATERAL PERIORBITAL SWELLING, A MIDLINE FRONTAL REGION HEMATOMA. PATIENT DISCHARGED.

  Patient problems: Epistaxis; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema; Vomiting

  MAUDE report 17511454 ↗
• MalfunctionApr 16, 2019Break

  IT WAS REPORTED THAT DURING AN ANTERIOR/POSTERIOR NASAL BLEED THE PATIENT WAS PACKED BI-LATERALLY WITH RAPID RHINO FOLLOWING TUMOUR DE-BULKING PROCEDURE. THEY DONT KNOW WHEN AND IF THE BALLOON WAS INFLATED. AS THE PATIENT WAS WAKING, THEY OBSERVED THAT THE PATIENT HAD DIFFICULTY BREATHING. THEY REMOVED THE RAPID RHINO AND OBSERVED THAT IT APPEAR TO HAVE COME APART. THE PIECE IN THE LARYNGOPHARYNX WAS REMOVED UNDER LARYNGOSCOPY. THEY ALSO REMOVED MORE MATERIAL FROM THE NASAL AIRWAY UNDER ENDOSCOPY. IMMEDIATE DE -GLOVING OF RAPID RHINO PACK WITH ALGINATE AND ENDING UP IN LARYNGEAL INLET. PATIENT COULD NOT BREATH, LARYNGOSCOPY WAS PERFORMED TO REMOVE ALGINATE FROM LARYNGEAL INLET, AND THE NOSE WAS PACKED WITH BIPP (BISMUTH IODINE PARAFFINE PASTE).

  Patient problems: Dyspnea

  MAUDE report 8520496 ↗
• InjuryApr 11, 2019Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A TREATMENT, THE BLUE SHEATH OF RAPID RHINO WAS NOT REMOVED PRIOR TO INSERTION, PRODUCING SEPTAL ABRASION AND EXACERBATION OF EPISTAXIS IN THE PATIENT. THE PACKING THAT WAS DONE WITH THE BLUE SHEATH ON WOULD NOT HAVE BEEN IN THAT LONG AS WHEN AN ENT DOCTOR IDENTIFIED THIS AND REMOVED IT. PATIENT WAS PACKED AGAIN USING A DISSOLVABLE PACKING, THEN CAUTERISED AND PACKED WITH NASOPORE, THEN WENT HOME.

  Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8503377 ↗