IceRod® 1.5 Cryoablation Needle
Catalogue number FPRPR3203, listed by Boston Scientific Corporation, United States, under Unit, Cryosurgical, Accessories. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-08-15 |
| Record revised | 2023-12-06 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Cool, Dry, Place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FPRPR3203 | Shaft Diameter 1.5 mm; Shaft Length 175 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Premier | Premier Dental Products Co. | 30 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| truFreeze | CSA Medical | 20 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243245 | 2024-10-18 |
| K234002 | 2024-03-13 |
| K232635 | 2023-11-22 |
| K230551 | 2023-08-08 |
| K961219 | 1996-06-21 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Boston Scientific Corporation | UDI-DI | 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 26 units |
Recalls
39 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-08-18 | Class II | Process control | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | 1 unit |
| 2025-08-18 | Class II | Process control | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | 18 units |
| 2025-03-24 | Class II | Process control | 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 a | 435 units |
| 2025-03-24 | Class II | Process control | 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 a | 31 units |
| 2025-03-24 | Class II | Process control | 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 a | 67 units |
| 2025-03-24 | Class II | Process control | 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 a | 244 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 211 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 772 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 4,645 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 86 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 525 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 6,363 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 245 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 115 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 419 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 947 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 627 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 8453 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 52 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 788 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 22,289 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 39 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 243 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 92 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 729 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 255 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 178 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 2,429 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 64 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 1,526 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 117 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 93 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 85 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 152 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 140 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 261 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 262 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 215 units |
| 2020-11-18 | Class II | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. | 75 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.