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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 3 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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