truFreeze CO8407030501Recalls & reported problems
US Endoscopy · truFreeze Aire PV Passive Venting Catheter Kit includes 7 Fr Catheter, Straight Spray Catheter Introducer and is used with the truFreeze Spray Cryotherapy System. · Class 2
All models of truFreeze (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995199289), received between Oct 18, 2023 and Feb 15, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Insufficient Flow or Under Infusion1
Patient problems
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2024Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Insufficient Flow or Under Infusion; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR AIRE PASSIVE VENTING CATHETER WAS NOT SPRAYING EVENLY RESULTING IN A 10-MINUTE PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18712606 ↗MalfunctionOct 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT A SMALL LINEAR TEAR WAS DETECTED IN A PATIENT WHILE UNDERGOING A PROCEDURE WHICH INCLUDED USE OF TRUFREEZE CRYOSPRAY THERAPY. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE PATIENT (CHEST TUBE AND HOSPITALIZATION).
Patient problems: Laceration(s)
MAUDE report 17958878 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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