truFreeze 20-00181Recalls & reported problems
Csa Medical, Inc. · 16 Fr. Active Venting Cryo Decompression Tube (Low Durometer) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857068006075), received between Jun 24, 2022 and Jun 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Hematemesis1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE USER FACILITY REPORTED THAT THEIR TRUFREEZE SYSTEM WAS NOT OPERATING PROPERLY DURING A PATIENT PROCEDURE. ADDITIONAL MEDICAL TREATMENT WAS ADMINISTERED FOLLOWING THE PROCEDURE.
Patient problems: Hematemesis; Insufficient Information
MAUDE report 14803500 ↗
Other Unit, Cryosurgical, Accessories devices
- IceFORCE® 2.1 CX 90° Cryoablation Needle FPRPR3602Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls4 deaths274 reports
- IceRod® 1.5 CX 90° Cryoablation Needle FPRPR3533Boston Scientific Corporation · Unit, Cryosurgical, Accessories1 recall168 reports
- IcePearl® 2.1 CX 90° Cryoablation Needle FPRPR3601Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls78 reports
- IceFORCE™ 2.1 CX L 90° Cryoablation Needle FPRPR3618Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls6 reports
- IceFORCE® 2.1 CX Cryoablation Needle FPRPR3604Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls3 reports
- IcePearl™ 2.1 CX L 90° Cryoablation Needle FPRPR3617Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls1 report
- IceRod® He-Thaw Prostate Cryoablation Kit / Presice® System FPRPR4570Galil Medical Ltd · Unit, Cryosurgical, Accessories2 recalls0 reports
- IceRod® i-Thaw® Prostate Cryoablation Kit / Presice® System FPRPR4070Galil Medical Ltd · Unit, Cryosurgical, Accessories2 recalls0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page