truFreeze 2000516Recalls & reported problems
US Endoscopy · Rapid AV Catheter Kit with 16 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introducer, 16 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00724995199326), received between Jul 12, 2024 and Sep 2, 2026 — classified as 1 injury, 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Break1
- Infusion or Flow Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Abrasion1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Insufficient Device Problem Information
Patient problems: Abrasion
MAUDE report 50570548 ↗MalfunctionApr 9, 2026Break
THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT, "PREPPING FOR CRYO CASE, TRUFREEZE CATHETER CAME BROKEN IN PACKAGE AND HAD TO BE REPLACED. TECHNICIAN NOTED PRIOR TO USE THAT THE WHITE CATHETER SECTION WAS BROKEN FROM THE BLACK SECTION". NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831399 ↗MalfunctionJan 2, 2026Leak/Splash
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ACTIVE VENTING SPRAY CATHETER BEGAN TO LEAK AFTER IT WAS CONNECTED TO THE TRUFREEZE CONSOLE AND THE CRYO FOOT PEDAL WAS ACTIVATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY USING A PULMONARY CATHETER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23946471 ↗MalfunctionJul 12, 2024Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT THREE OF THEIR RAPID AV SPRAY CATHETERS WOULD NOT SPRAY PROPERLY RESULTING TO A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19731411 ↗
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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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