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truFreeze
US Endoscopy · Model 2000516 · UDI-DI 00724995199326
GEH
Prescription
3
510(k) clearances
3,274
Adverse events (57 deaths)
107
Recalls
112
Facilities
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-24 | Limitless Cryo Spa LLC | Lack of 510(k) clearance. |
| 2026-06-26 | Erbe USA Inc | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the |
| 2026-02-12 | Erbe USA Inc | Probes may rupture/burst during activation |
| 2026-02-12 | Erbe USA Inc | Probes may rupture/burst during activation |
| 2026-02-12 | Erbe USA Inc | Probes may rupture/burst during activation |
| 2025-08-18 | Boston Scientific Corporation | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. |
| 2025-08-18 | Boston Scientific Corporation | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.