POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor
510(k) K223824
Active
Valid until
Not listed
FDA recalls
1 ongoingTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK223824 | Date22 Mar 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
-
- Ongoing Z-1302-2024
Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DRA
- FDA applicant
- Boston Scientific Corporation
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1280
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device comprises a steerable sheath, circular mapping catheter, electrical cables, and temperature/pressure sensors designed for electrophysiological (EP) procedures. The PolarSheath Steerable Sheath 12F facilitates catheter navigation within the heart, while the PolarMap Circular Mapping Catheter enables detailed mapping of cardiac electrical activity. The SmartFreeze Esophageal Temperature Sensor Cables and Pressure Sensor support cryoablation procedures by monitoring temperature and pressure during freezing applications, ensuring precise and controlled therapy delivery.
These components are intended for use in electrophysiology laboratories and cardiac catheterization suites, typically in conjunction with cryoablation systems. Supplied as reusable medical devices, they require proper sterilization and maintenance per manufacturer guidelines. The devices are classified as Class II under FDA regulations and comply with the Medical Device Regulation (MDR) in the EU. Each component is assigned a unique product number for traceability and regulatory tracking, ensuring adherence to global medical device standards.
Other devices from Boston Scientific
Questions
AI-generated answers, 18 Sep 2026
Are these devices single-use or reusable, and what maintenance is required if they are reusable?
These devices are designed for reusable use in electrophysiology procedures. Since they include components like the PolarSheath Steerable Sheath, PolarMap Circular Mapping Catheter, and SmartFreeze sensors, proper sterilization and maintenance per manufacturer guidelines are essential to ensure safety and performance. Boston Scientific provides specific instructions for cleaning, sterilization, and inspection to maintain functionality between uses.
What is the primary purpose of the SmartFreeze Esophageal Temperature Sensor Cables and Pressure Sensor in these procedures?
The SmartFreeze Esophageal Temperature Sensor Cables and Pressure Sensor are used to monitor temperature and pressure during cryoablation—a procedure where freezing is applied to treat cardiac arrhythmias. These sensors ensure precise control of the freezing process, helping to deliver safe and effective therapy by preventing excessive tissue damage or inadequate treatment.
How are these devices regulated, and what does that mean for purchasing or using them?
These devices are regulated under FDA 510(k) clearance (Class II) and comply with the EU Medical Device Regulation (MDR). The FDA’s clearance indicates they meet safety and effectiveness standards for electrophysiological applications, while MDR compliance ensures they adhere to EU requirements for market placement. Purchasers should confirm local regulatory compliance before use, as these classifications may impact procurement and clinical implementation.
What sizes or models are available for the PolarSheath Steerable Sheath, and how does that affect procedure planning?
The PolarSheath Steerable Sheath is available in a 12 French (12F) size, which is a standard diameter for catheter navigation within the heart. This size is chosen to balance maneuverability and stability during electrophysiological procedures, particularly in complex arrhythmia mappings. Clinicians should verify compatibility with their specific patient anatomy and procedural needs before use.
Are there different types of SmartFreeze Esophageal Temperature Sensor Cables, and when would a clinician choose one over another?
Yes, there are three variants of the SmartFreeze ETS Cable: the standard Esophageal Temperature Sensor Cable, the 16 PIN Esophageal Temperature Sensor Cable, and the CIRCA Esophageal Temperature Sensor Cable. The choice depends on the cryoablation system compatibility and specific monitoring requirements. For example, the 16 PIN version may offer additional data channels, while the CIRCA variant could be optimized for certain ablation platforms. Consult the manufacturer’s documentation to match the cable to your system.