LTV 29657-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10190752115934), received between Apr 23, 2021 and Mar 31, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Device Alarm System; Gas Output Problem

  IT WAS REPORTED THAT DURING USE ON A 55-YEAR-OLD FEMALE, THE CIRCUIT CAUSED THE VENTILATOR TO INAPPROPRIATELY SET OFF AN ALARM AND CAUSED RAPID TRIGGERING, NOT ALLOWING THE PATIENT TO TAKE NORMAL BREATHS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. THE CUSTOMER'S REPORT IS AGAINST TWO CIRCUITS FROM THE SAME LOT NUMBER AND IT IS NOTED THAT THE CIRCUITS WERE DISPOSED OF AND ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746817 ↗
• MalfunctionMar 18, 2026Mechanical Problem

  IT WAS REPORTED THAT ONCE IN USE, THE PATIENT STATED THAT THE CIRCUIT APPEARED TO CAUSE THE VENTILATOR TO MALFUNCTION, RESULTING IN RAPID TRIGGERING AND PREVENTING THE PATIENT FROM TAKING NORMAL BREATHS. BOTH CIRCUITS WITH MATCHING LOT NUMBER 0004309572 PRODUCED THE SAME VENTILATOR RESPONSE. THE PATIENT REPLACED THE CIRCUITS WITH A BACKUP CIRCUIT OF THE SAME ITEM ID (29657001) BUT A DIFFERENT LOT NUMBER, AFTER WHICH THE VENTILATOR CEASED RAPID TRIGGERING. THE PATIENT REPORTED THAT THE VENTILATOR HAD NOT EXHIBITED SIMILAR ISSUES PREVIOUSLY. NO HARM WAS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT DISCARDED THE CIRCUITS AFTER THE EVENT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 24627606 ↗
• MalfunctionApr 5, 2024Crack; Crack

  IT WAS REPORTED TO VYAIRE MEDICAL THAT ITEM 29657-001 CIRCUIT PATIENT ADULT W/O PEEP VALVE 22MM SPU DEHP-FREE IS FAULTY FOR USE IN THE HOSPITAL.THERE ARE LEAKS IN THE CIRCUITS CAUSING LOW VOLUMES. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052206 ↗
• MalfunctionApr 2, 2024

  PATIENT CIRCUIT W/O PEEP (POSITIVE END-EXPIRATORY PRESSURE), 22MM, SPU----UNABLE TO VENTILATE PATIENTS DUE TO LEAKS IN THE SYSTEM. THIS HAS HAPPENED ON SEVERAL OCCASIONS.

  Patient problems: Insufficient Information

  MAUDE report 19018498 ↗
• MalfunctionJan 17, 2023Component Missing; Detachment of Device or Device Component

  VENT TUBING CAME UNHOOKED FROM VENTILATOR. THERE IS NOTHING IN THE PRODUCT DESIGN TO KEEP THE TUBING FROM DISCONNECTING FROM THE VENT IE; NO LEUR LOCK, SNAP & LOCK, ETC. IN THIS SCENARIO THE VENT USED WAS A LTV 1200. THE TUBING DISCONNECTED FROM THE VENTILATOR ITSELF DURING PROCEDURE. VENTILATOR DID ALARM. SUGGEST A PRODUCT IMPROVEMENT COULD BE MADE FOR SECURING TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183444 ↗
• InjuryApr 26, 2022Defective Device; Defective Device

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 29657-001 PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG) STOP WORKING AFTER JUST FIVE MINUTES OF USING, RESULTED TO PATIENTS INCREASE RESPIRATORY RATE TO FORTY BREATHS PER MINUTE AND THE PATIENT CANNOT BREATH. AS AN INTERVENTION, THE CIRCUIT REPLACED WITH A BACKUP DEVICE.

  Patient problems: Increased Respiratory Rate

  MAUDE report 14215383 ↗
• InjuryApr 26, 2022Defective Device; Defective Device

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 29657-001 PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG) STOP WORKING AFTER JUST FIVE MINUTES OF USING, RESULTED TO PATIENTS INCREASE RESPIRATORY RATE TO FORTY BREATHS PER MINUTE AND THE PATIENT CANNOT BREATH. AS AN INTERVENTION, THE CIRCUIT REPLACED WITH A BACKUP DEVICE.

  Patient problems: Increased Respiratory Rate

  MAUDE report 14215364 ↗
• InjuryNov 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 29657-001- PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG) WAS LEAKING AIR AROUND A PROXIMAL PORT WHEN CONNECTED TO THE VENTILATOR, CAUSING THE VENTILATOR TO LOCK UP. THE DEFECTIVE CIRCUIT WAS REPLACED AND THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775034 ↗
• MalfunctionApr 23, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE THE LAP TOP VENTILATOR EXPERIENCED "DISC/SENSE," ALARM WHILE CONNECTED TO A PATIENT. THIS ISSUE WAS LINKED TO THE 29657-001 PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG). THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721217 ↗