Rapid RhinoRecalls & reported problems across all models
Smith & Nephew, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 5 models of Rapid Rhino by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2019 and Dec 24, 2025 — classified as 18 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Rapid Rhino problems
Device problems
- Material Integrity Problem11
- Detachment of Device or Device Component9
- Break7
- Material Discolored2
- Material Disintegration2
- Material Split, Cut or Torn2
- Protective Measures Problem2
- Device Alarm System1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Headache11
- Pain11
- Hemorrhage/Blood Loss/Bleeding3
- Dyspnea2
- Abrasion1
- Airway Obstruction1
- Blood Loss1
Rapid Rhino models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Rapid Rhino RR 750BALLOON, EPISTAXIS13 reports
- Rapid Rhino RR1000SPLINT, INTRANASAL SEPTAL12 reports
- Rapid Rhino RR 900BALLOON, EPISTAXIS7 reports
- Rapid Rhino RR 800SPLINT, INTRANASAL SEPTAL3 reports
- Rapid Rhino RR 550BALLOON, EPISTAXIS2 reports
Recent Rapid Rhino adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 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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