Rapid Rhino RR 900Recalls & reported problems
Smith & Nephew, Inc. · RAPID RHINO 9CM INFATABLE DUAL BALLOON · Class 1
All models of Rapid Rhino (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00817470000504), received between Apr 16, 2019 and Jun 3, 2025 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Material Disintegration2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Airway Obstruction1
- Blood Loss1
- Dyspnea1
- Foreign Body In Patient1
- Low Oxygen Saturation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Material Disintegration; Material Disintegration
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE RAPID RHINO ANTERIOR/POSTERIOR DUAL DISINTEGRATED WITHIN THE NOSE OF THE PATIENT BEFORE REMOVAL. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22129368 ↗MalfunctionJun 2, 2025Material Disintegration; Material Disintegration
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE RAPID RHINO ANTERIOR/POSTERIOR DUAL DISINTEGRATED WITHIN THE NOSE OF THE PATIENT BEFORE REMOVAL. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22129365 ↗MalfunctionFeb 20, 2024Break; Break
IT WAS REPORTED THAT THE RAPID RHINO DUAL BROKE WHEN IT WAS BEING REMOVED FROM THE PATIENT. THE DEVICE WAS REMOVED USING ANOTHER DEVICE TO HELP IN THE REMOVAL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18742668 ↗MalfunctionFeb 14, 2024Break; Break
IT WAS REPORTED THAT AFTER A PROCEDURE WHERE A RAPID RHINO WAS USED; WHEN THE PATIENT CAME IN FOR REMOVAL OF THE PRODUCT, THE DEVICE´S PART WHICH IS USED TO HOLD TO REMOVE THE INSIDE PART BROKE OFF, SO THE NURSES HAD TO USE AN UNSPECIFIED DEVICE TO REMOVE IT FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18704370 ↗InjuryFeb 7, 2024Break; Break
IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE PATIENT IN QUESTION HAD BILATERAL PACKS IN SITU AND WAS STRUGGLING TO BREATHE DUE TO AN OBSTRUCTION IN THE BACK OF THE THROAT. AFTER INSPECTION, IT WAS NOTICED THE RAPID RHINO HAD SEPARATED INTO TWO PIECES AND HAD TO BE REMOVED IN RESPONSE TO THE EMERGENCY. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Airway Obstruction
MAUDE report 18663893 ↗InjuryJul 13, 2021Break; Break
IT WAS REPORTED THAT THE 9CM ANTERIOR/POSTERIOR DUAL WAS USED TO STOPPED A STRONG BLEEDING, BUT IT BROKE WHEN IT WAS REMOVING FROM THE PATIENT. THE BROKEN PART WAS REMOVED FROM THE THROAT AND THE BLEEDING COULD BE CALMED. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. OTHER COMPLICATIONS WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12160780 ↗InjuryApr 16, 2019Break
IT WAS REPORTED THAT PATIENT WAS WAKING FROM ANESTHESIA AND IT WAS OBSERVED THAT PATIENT HAD DIFFICULTY BREATHING. THEY REMOVED THE RAPID RHINO AND IT APPEARED TO HAS COME APART. THE PATIENT DE SATURATED AND BLOOD COULD BE HEARD GURGLING. THE PIECE IN THE LARYNGOPHARYNX WAS REMOVED UNDER LARYNGOSCOPY. THEY ALSO REMOVED MORE MATERIAL FROM THE NASAL AIRWAY UNDER ENDOSCOPY. PATIENT IS FULLY RECOVERED.
Patient problems: Blood Loss; Dyspnea; Foreign Body In Patient; Low Oxygen Saturation
MAUDE report 8519689 ↗
Other BALLOON, EPISTAXIS devices
- Rapid Rhino RR 750Smith & Nephew, Inc. · BALLOON, EPISTAXIS13 reports
- Rapid Rhino RR 550Smith & Nephew, Inc. · BALLOON, EPISTAXIS2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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