Set, Tubing And Support, Ventilator (W Harness)

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-06-30Open, ClassifiedComponent design/selection

  Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

  Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement

• 2025-10-14Open, ClassifiedDevice Design

  Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

  IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.

• 2025-07-30Open, ClassifiedProcess control

  Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

  Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.

• 2025-04-03Open, ClassifiedUnder Investigation by firm

  Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable

  The potential for cracks forming in the breathing circuit hose.

• 2024-09-27Open, ClassifiedDevice Design

  Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

  Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

• 2024-09-27Open, ClassifiedDevice Design

  Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

  Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

• 2023-09-09Open, ClassifiedUnder Investigation by firm

  Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

  The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

• 2023-05-17TerminatedProcess control

  ID Circuit Basic (P) 180, MP01340

  Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

• 2023-05-17TerminatedProcess control

  VentStar Coax (P) 150, MP00379

  Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

• 2023-05-17TerminatedProcess control

  Ventstar Coax, MP03373

  Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.