truFreeze 2000177Recalls & reported problems
US Endoscopy · Rapid AV Catheter Kit with 20 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introducer, 20 Fr CryoDecompression Tube (CDT), Dual Lumen, Connector, Suction Tubing and is used with the truFreeze Spray Cryotherapy System. · Class 2
All models of truFreeze (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995199227), received between Mar 29, 2023 and Aug 29, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information5
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Pain2
- Perforation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING TWO PATIENT PROCEDURES, THE RAPID AV CATHETER BROKE IN THE CHANNEL OF THE SCOPE. FOLLOWING A DELAY, USER FACILITY PERSONNEL UTILIZED ANOTHER CATHETER TO COMPLETE THE PATIENT PROCEDURES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20099833 ↗MalfunctionJun 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT THEIR TRUEFREEZE CONSOLE WAS UNABLE TO SCAN THE CATHETER POUCH SUCCESSFULLY. THE CUSTOMER COMPLETED PROCEDURE WITH ANOTHER CATHETER, SUBSEQUENTLY CAUSING THE PATIENT PROCEDURE TO BE DELAYED. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19516180 ↗MalfunctionJul 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT A PATIENT HAD A LINEAR TEAR NEAR THE MID-ESOPHAGUS A FEW WEEKS AFTER UNDERGOING A PROCEDURE TO TREAT A TUMOR WHICH INCLUDED USE OF TRUFREEZE CRYOSPRAY THERAPY. THE PATIENT HAD DEVELOPED PNEUMOMEDIASTINUM AND SOUGHT AND RECEIVED ADDITIONAL MEDICAL INTERVENTION.
Patient problems: Pain
MAUDE report 17276718 ↗MalfunctionJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT A PERFORATION WAS DETECTED IN A PATIENT AFTER UNDERGOING A PROCEDURE WHICH INCLUDED USE OF TRUFREEZE CRYOSPRAY THERAPY. AN ADDITIONAL PROCEDURE WAS REQUIRED TO TREAT THE PATIENT.
Patient problems: Perforation
MAUDE report 17171018 ↗MalfunctionMay 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT A PATIENT WAS EXPERIENCING PAIN ONE WEEK AFTER UNDERGOING A PROCEDURE WHICH INCLUDED USE OF TRUFREEZE CRYOSPRAY THERAPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT SOUGHT AND RECEIVED ADDITIONAL MEDICAL INTERVENTION (X-RAY).
Patient problems: Pain
MAUDE report 16915309 ↗MalfunctionMar 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE RAPID AV SPRAY CATHETER TO THEIR TRUFREEZE CONSOLE SPRAYED BLACK RESIDUE ONTO THE PATIENT'S TISSUE ON THE INITIAL SPRAY. THE PROCEDURE WAS COMPLETED WITH THE SAME CATHETER. NO REPORT OF INJURY. NO REPORT OF PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16638210 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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