Unit, Cryosurgical, Accessories
FDA adverse event reports and recall history for unit, cryosurgical, accessories (product code GEH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,185
- Deaths
- 57
- Injuries
- 813
- Malfunctions
- 2,219
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-03-20Open, ClassifiedProcess control
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Probes may rupture/burst during activation
- 2026-03-20Open, ClassifiedProcess control
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Probes may rupture/burst during activation
- 2026-03-20Open, ClassifiedProcess control
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Probes may rupture/burst during activation
- 2025-09-11Open, ClassifiedProcess control
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- 2025-09-11Open, ClassifiedProcess control
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- 2025-04-29Open, ClassifiedProcess control
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
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 (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
- 2025-04-29Open, ClassifiedProcess control
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
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 (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
- 2025-04-29Open, ClassifiedProcess control
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
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 (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
- 2025-04-29Open, ClassifiedProcess control
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
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 (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
- 2025-02-05Open, ClassifiedDevice Design
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
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