HUDSON RCI IPN046758Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04026704588770), received between Aug 29, 2024 and Apr 15, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Material Rupture

  IT WAS REPORTED THAT: "AFTER INTUBATION, IT WAS DISCOVERED THERE WAS A LEAK IN THE BALLOON AND THEN THE BALLOON LATER BURST."

  Patient problems: Insufficient Information

  MAUDE report 24884446 ↗
• MalfunctionFeb 26, 2026Gas/Air Leak

  IT WAS REPORTED THAT "CUFF LEAK DURING USE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24453386 ↗
• MalfunctionMar 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT: "CUFFS POPPING. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523677 ↗
• MalfunctionSep 4, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: " ETTS, THE CUFF INFLATED BUT THE PILOT REMAINS FLAT". THE ISSUE WAS IDENTIFIED PRIOR TO USE. ASSOCIATED COMPLAINTS 3003898360-2024-01158, 3003898360-2024-01161, 3003898360-2024-01160 AND 3003898360-2024-01159.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136621 ↗
• MalfunctionSep 4, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: " ETTS, THE CUFF INFLATED BUT THE PILOT REMAINS FLAT". THE ISSUE WAS IDENTIFIED PRIOR TO USE. ASSOCIATED COMPLAINTS 3003898360-2024-01158, 3003898360-2024-01161, 3003898360-2024-01160 AND 3003898360-2024-01159.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136542 ↗
• MalfunctionSep 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: " ETTS, THE CUFF INFLATED BUT THE PILOT REMAINS FLAT". THE ISSUE WAS IDENTIFIED PRIOR TO USE. ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20123253 ↗
• MalfunctionSep 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: " ETTS, THE CUFF INFLATED BUT THE PILOT REMAINS FLAT". THE ISSUE WAS IDENTIFIED PRIOR TO USE. ASSOCIATED COMPLAINTS 3003898360-2024-01158, 3003898360-2024-01160 AND 3003898360-2024-01161.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20123242 ↗
• MalfunctionSep 2, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: " ETTS, THE CUFF INFLATED BUT THE PILOT REMAINS FLAT". THE ISSUE WAS IDENTIFIED PRIOR TO USE. ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20117164 ↗
• MalfunctionSep 2, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: " ETTS, THE CUFF INFLATED BUT THE PILOT REMAINS FLAT". THE ISSUE WAS IDENTIFIED PRIOR TO USE.

  Patient problems: Insufficient Information

  MAUDE report 20117142 ↗
• MalfunctionAug 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "RT DEPT, WAS TOLD BY ICU PHYSICIAN THAT THE CUFF WAS LEAKING." THE ETT WAS EXCHANGED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096582 ↗

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-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-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-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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
• 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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• Z-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 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/
• 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-1761-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-2
• 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-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

…and 12 more.