SHERIDAN IPN926930Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 14026704759252), received between Feb 16, 2023 and Aug 15, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Disconnection” (4 reports).

27 other recalls cover devices cleared under the same FDA submission (K822082); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023Disconnection; Disconnection

  REPORTED VIA A MEDWATCH REPORT, "PATIENT INTUBATED IN THE EMERGENCY DEPARTMENT ON(B)(6) 2023 WITH A 7.5 SHERIDAN ETT. ON (B)(6) 2023 PATIENT UNDERWENT A TUBE EXCHANGE DUE TO FREQUENT DISCONNECTIONS FROM THE ETT HUB. AFFECTED ETT WAS SEQUESTERED AND DELIVERED TO RESPIRATORY THERAPY LEADERSHIP FOR FOLLOW UP." ADDITIONAL INFORMATION STATES THAT IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY DESATURATION. IT IS ALSO UNKNOWN WHAT THE CURRENT STATUS OF THE PATIENT IS.

  Patient problems: Insufficient Information

  MAUDE report 17551098 ↗
• MalfunctionAug 15, 2023Connection Problem; Connection Problem

  IT WAS REPORTED VIA MEDWATCH REPORT, "PATIENT ETT POPPED OFF FROM THE HUB FIVE TIMES. ANESTHESIA REPLACED THE ETT". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17550910 ↗
• MalfunctionJul 31, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED BY THE ED ATTENDING. A FIBEROPTIC LARYNGOSCOPE WAS USED TO INTUBATE, THE PROCEDURE WAS DESCRIBED AS NORMAL. AFTER THE PATIENT WAS CONNECTED TO THE VENTILATOR, IT WAS FOUND THAT THE CUFF WAS UNABLE TO REMAIN INFLATED. THERE WAS NO PATIENT HARM, DESATURATION, OR INJURY. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17429390 ↗
• MalfunctionJul 18, 2023Disconnection; Disconnection

  REPORTED VIA MEDWATCH, "PATIENT ADMITTED TO THE SICU STATUS POST OPEN-HEART SURGERY. BROUGHT TO UNIT INTUBATED, DURING TIME ON THE ICU ETT (ENDOTRACHEAL TUBE) POPPED OFF MULTIPLE TIMES AS DESCRIBED IN RECENT RECALL. ETT APPEARED TO BE THE OLD TUBE WHICH WAS RECALLED. OLD TUBES WERE SUPPOSED TO HAVE BEEN SWAPPED OUT. PATIENT BECAME UNSTABLE AND NEEDED EMERGENT CT SCAN, TUBE REQUIRED TAPE TO STAY IN PLACE IN ORDER TO SAFELY TRAVEL TO SCAN. ETCO2 (END-TIDAL CARBON DIOXIDE) WAS USED AT ALL TIMES." ADDITIONAL INFORMATION WAS ASKED TO THE CUSTOMER REGARDING PATIENT HARM OR INJURY AND CURRENT CONDITION, AS WELL AS DETAILS SURROUNDING THE EVENT. THE CUSTOMER RESPONDED BUT DID NOT HAVE ANSWERS TO ANY OF THESE QUESTIONS. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17341663 ↗
• MalfunctionJul 11, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE BALLOON DOES NOT HOLD INFLATION. AS A RESULT, A NEW ETT WAS USED HOWEVER, THE SAME ISSUE OCCURRED. A THIRD ETT WAS USED AND WAS SUCCESSFUL. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR #3003898360-2023-01047.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298288 ↗
• MalfunctionJul 11, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE BALLOON DOES NOT HOLD INFLATION. AS A RESULT, A NEW ETT WAS USED HOWEVER, THE SAME ISSUE OCCURRED. A THIRD ETT WAS USED AND WAS SUCCESSFUL. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".SEE ASSOCIATED MDR #3003898360-2023-01031.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298193 ↗
• MalfunctionJul 5, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT DURING USE, THE 15MM CONNECTOR AT THE PROXIMAL END OF THE TUBE BECAME DISCONNECTED. PER THE CUSTOMER, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY OXYGEN DESATURATION. NO PATIENT HARM OR INJURY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN PER THE CUSTOMER. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263742 ↗
• MalfunctionMay 30, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT DURING INTUBATION, THE CONNECTOR KEPT "POPPING OUT". NO PATIENT HARM OR INJURY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN AND PER THE CUSTOMER NO FURTHER INFORMATION WILL BE AVAILABLE. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022686 ↗
• MalfunctionMar 6, 2023Failure to Disconnect; Failure to Disconnect

  REPORTED ISSUE: ET TUBE DISCONNECTS.

  Patient problems: Insufficient Information

  MAUDE report 16488784 ↗
• MalfunctionMar 6, 2023Connection Problem; Connection Problem

  REPORTED ISSUE: ET TUBE DISCONNECTS.

  Patient problems: Insufficient Information

  MAUDE report 16488433 ↗
• MalfunctionFeb 16, 2023Connection Problem; Connection Problem

  REPORTED EVENT: A DISCONNECTION OCCURRED. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16386582 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K822082. One submission often covers many models, so check the product and lot details in each record.

• Z-2314-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009,
• Z-2312-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10
• Z-2311-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
• Z-2318-2019 · Jul 30, 2019 · Terminated
  Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
• Z-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
• Z-2315-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g)
• Z-2316-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm,
• Z-2313-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0
• Z-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• Z-1762-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-222
• Z-1766-2019 · May 24, 2019 · Terminated
  Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-
• Z-1760-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm,
• Z-1764-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0
• Z-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
• Z-1763-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/

…and 12 more.