SHERIDANRecalls & reported problems across all models
Teleflex Incorporated · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 67
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 19 models of SHERIDAN by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2023 and Sep 23, 2026 — classified as 9 injuries, 58 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (18 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 SHERIDAN problems
Device problems
- Gas/Air Leak18
- Leak/Splash14
- Disconnection7
- Inflation Problem6
- Material Too Soft/Flexible4
- Connection Problem3
- Physical Resistance/Sticking3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- Insufficient Information14
- Low Oxygen Saturation4
- Airway Obstruction1
- Respiratory Arrest1
- Unintended Extubation1
- Upper Respiratory Tract Injury1
SHERIDAN models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SHERIDAN IPN926930Tube, tracheal (w/wo connector)11 reports
- SHERIDAN 5-16035TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)9 reports
- SHERIDAN 5-16037TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)8 reports
- SHERIDAN IPN926926Tube, tracheal (w/wo connector)7 reports
- SHERIDAN 5-10314Tube, tracheal (w/wo connector)5 reports
- SHERIDAN IPN931410Tube, tracheal (w/wo connector)5 reports
- SHERIDAN IPN926927Tube, tracheal (w/wo connector)3 reports
- SHERIDAN IPN926929Tube, tracheal (w/wo connector)3 reports
- SHERIDAN IPN926931Tube, tracheal (w/wo connector)3 reports
- SHERIDAN IPN926899Tube, tracheal (w/wo connector)3 reports
- SHERIDAN IPN926875Tube, tracheal (w/wo connector)2 reports
- SHERIDAN IPN926869Tube, tracheal (w/wo connector)1 report
- SHERIDAN IPN926884Tube, tracheal (w/wo connector)1 report
- SHERIDAN IPN926895Tube, tracheal (w/wo connector)1 report
- SHERIDAN IPN926900Tube, tracheal (w/wo connector)1 report
- SHERIDAN 5-10106Tube, tracheal (w/wo connector)1 report
- SHERIDAN 5-10312Tube, tracheal (w/wo connector)1 report
- SHERIDAN 5-10315Tube, tracheal (w/wo connector)1 report
- SHERIDAN 5-16028TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 report
Recent SHERIDAN adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871282 ↗MalfunctionSep 15, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774671 ↗MalfunctionSep 1, 2026Disconnection
Patient problems: Low Oxygen Saturation
MAUDE report 50534433 ↗MalfunctionAug 31, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533791 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289577 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289517 ↗MalfunctionJul 14, 2026Leak/Splash
IT WAS REPORTED THAT "CCU 1 WAS INITIALLY INTUBATED ON JUNE 12 AT 23:27 WITH AN 8.0 ETT. PATIENT SELF-EXTUBATED ON JUNE 13 AT 00:24 AND WAS REINTUBATED BY MD AND PA WITH A 2ND 8.0 ETT. MD NOTICED THAT THE BALLOON WAS DEFLATING WITHIN 30 SECONDS, AND AN AUDIBLE LEAK WAS HEARD. WE OPENED A 7.5 ETT, AND IT WAS SAFELY EXCHANGED WITH A BOUGIE AFTER CHECKING PATENCY. THE TEAM THAT WAS PRESENT DURING BOTH INTUBATIONS DEBRIEFED AND CONFIRMED THAT BOTH ETTS WERE CHECKED FOR PATENCY AND CUFF INTEGRITY PRIOR TO PLACEMENT. FOLLOWING PHYSICAL ASSESSMENT OF THE 1ST AND 2ND ETTS, IT WAS NOTED THAT BOTH CUFFS EXHIBITED A SLOW AIR LEAK, RESULTING IN GRADUAL CUFF DEFLATION." ADDITIONAL INFORMATION RECEIVED ON JUNE 30, 2026, INDICATED THAT "THE PATIENT HAD DESATURATED 10-20%." TWO DEVICES INVOLVED. ASSOCIATED MDRS: 3003898360-2026-00304 AND 3003898360-2026-00303.
Patient problems: Low Oxygen Saturation
MAUDE report 25814622 ↗InjuryJul 14, 2026Leak/Splash
IT WAS REPORTED THAT "CCU 1 WAS INITIALLY INTUBATED ON (B)(6) AT 23:27 WITH AN 8.0 ETT. PATIENT SELF-EXTUBATED ON (B)(6) AT 00:24 AND WAS REINTUBATED BY MD AND PA WITH A 2ND 8.0 ETT. MD NOTICED THAT THE BALLOON WAS DEFLATING WITHIN 30 SECONDS, AND AN AUDIBLE LEAK WAS HEARD. WE OPENED A 7.5 ETT, AND IT WAS SAFELY EXCHANGED WITH A BOUGIE AFTER CHECKING PATENCY. THE TEAM THAT WAS PRESENT DURING BOTH INTUBATIONS DEBRIEFED AND CONFIRMED THAT BOTH ETTS WERE CHECKED FOR PATENCY AND CUFF INTEGRITY PRIOR TO PLACEMENT. FOLLOWING PHYSICAL ASSESSMENT OF THE 1ST AND 2ND ETTS, IT WAS NOTED THAT BOTH CUFFS EXHIBITED A SLOW AIR LEAK, RESULTING IN GRADUAL CUFF DEFLATION." ADDITIONAL INFORMATION RECEIVED ON JUNE 30, 2026, INDICATED THAT "THE PATIENT HAD DESATURATED 10-20%." TWO DEVICES INVOLVED. ASSOCIATED MDRS: 3003898360-2026-00304.
Patient problems: Low Oxygen Saturation
MAUDE report 25814592 ↗MalfunctionJul 13, 2026Leak/Splash
IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON A PATIENT. CHANGED THE SECOND TUBE; THE SECOND TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A THIRD TUBE; THE THIRD TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A FOURTH TUBE, WHICH WAS USED NORMALLY." ASSOCIATED MDRS: 3003898360-2026-00323, 3003898360-2026-00295 AND 3003898360-2026-00297.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25808427 ↗MalfunctionJul 13, 2026Leak/Splash
IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON A PATIENT. CHANGED THE SECOND TUBE; THE SECOND TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A THIRD TUBE; THE THIRD TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A FOURTH TUBE, WHICH WAS USED NORMALLY." ASSOCIATED MDRS: 3003898360-2026-00323, 3003898360-2026-00295.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25808408 ↗MalfunctionJul 13, 2026Leak/Splash
IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON A PATIENT. CHANGED THE SECOND TUBE; THE SECOND TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A THIRD TUBE; THE THIRD TUBE ALSO HAD CUFF LEAKAGE. CHANGED TO A FOURTH TUBE, WHICH WAS USED NORMALLY." ASSOCIATED MDRS: 3003898360-2026-00295 AND 3003898360-2026-00297.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25808373 ↗MalfunctionJul 7, 2026Leak/Splash
IT WAS REPORTED THAT "THE TUBE PRE-TEST PASSED. THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON A PATIENT. CHANGE TO A NEW TUBE." NO REPORT OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25742041 ↗MalfunctionJul 1, 2026Leak/Splash
IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE." NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25681053 ↗MalfunctionJun 30, 2026Material Deformation
IT WAS REPORTED THAT "DURING A NEUROSURGERY CASE (VP SHUNT), THE HEAD WAS FLEXED MOMENTARILY SO THAT THE HEAD COULD BE PREPPED FOR SURGERY. AFTER THE NECK WAS FLEXED, THE VENTILATION BECAME IMPAIRED. WE WERE UNABLE TO EFFECTIVELY VENTILATE THE PATIENT THROUGH THIS ETT DESPITE THE NECK RETURNED TO A NEUTRAL POSITION. AN APPROPRIATELY SIZED SUCTION CATHETER WAS PASSED INTO THIS ETT, AND IT WOULD NOT PASS COMPLETELY THROUGH. THERE WERE NO SECRETIONS. A FLEXIBLE BRONCHOSCOPE WAS PLACED AND IDENTIFIED A COMPLETE NARROWING WITHIN THE ETT AT A POINT BEYOND THE PATIENT'S VOCAL CORDS, SOMEWHERE WITHIN THE TRACHEA. DECISION MADE TO EXTUBATE THE PATIENT AND REINTUBATE WITH ANOTHER ETT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669018 ↗MalfunctionMay 15, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT "THE RT'S NOTICED THE DEPTH MARKINGS ARE UP TO 0.5CM OFF MEASUREMENT." ADDITIONAL INFORMATION RECEIVED ON APRIL 25, 2026, INDICATED THAT "NO PATIENT INJURY OR CONSEQUENCE REPORTED, NO MEDICAL INTERVENTION REQUIRED. THE PATIENT STATUS IS REPORTED AS "FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191118 ↗
Other Teleflex Incorporated products
- ARROW1,494 models · 9,043 reports · 62 recalls
- RUSCH220 models · 436 reports · 130 recalls
- WECK97 models · 3,790 reports · 1 recall
- HUDSON RCI152 models · 1,461 reports · 7 recalls
- LANGSTON4 models · 15 reports · 5 recalls
- PLEUR-EVAC15 models · 146 reports · 1 recall
- LMA AIRWAY MANAGEMENT47 models · 139 reports
- UROLIFT13 models · 137 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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