Rapid Rhino RR 550Recalls & reported problems
Smith & Nephew, Inc. · RAPID RHINO 5.5CM INFLATABLE UNILATERAL WITHOUT AIRWAY · Class 1
All models of Rapid Rhino (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470006629), received between Oct 9, 2025 and Dec 24, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2025Break; Break
IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE BALLOON TUBE AT THE BASE OF THE 5.5 CM RAPID RHINO DEVICE BROKE DURING REMOVAL. IT WAS NECESSARY TO REMOVE THE DEVICE USING LONG-NOSE FORCEPS THROUGH THE NOSE. THE PROCEDURE WAS THEN COMPLETED USING THE SAME DEVICE. IT IS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888269 ↗InjuryOct 9, 2025Labelling, Instructions for Use or Training Problem; Device Dislodged or Dislocated; Labelling, Instructions for Use or Training Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER AN ENT SURGERY, AN MRI SCAN WAS PERFORMED ON A PATIENT WHO HAD BEEN FITTED WITH TWO (2) RAPID RHINO DEVICES. THE MRI SHOWED THAT BOTH DEVICES HAD MOVED, ONE TOWARD THE PHARYNX AND THE OTHER OUT OF THE NOSE. THE DEVICE THAT MOVED TOWARD THE PHARYNX WAS RETRIEVED THROUGH THE NOSE. THESE DEVICES CONTAINED A METAL SPRING. THE INSTRUCTIONS FOR USE OF THE DEVICE DID NOT MENTION IN THE CONTRAINDICATIONS SECTION THAT MAGNETIC RESONANCE IMAGING SHOULD BE AVOIDED FOR PATIENTS WHO HAVE BEEN FITTED WITH A RAPID RHINO. THE EVENT CAUSED BLEEDING TO THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 23255518 ↗
Other BALLOON, EPISTAXIS devices
- Rapid Rhino RR 750Smith & Nephew, Inc. · BALLOON, EPISTAXIS13 reports
- Rapid Rhino RR 900Smith & Nephew, Inc. · BALLOON, EPISTAXIS7 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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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