Model note · IVUS
Boston Scientific OptiCross HD / OptiCross 6 HD 60 MHz coronary imaging catheter
OptiCross HD is a single-use, short-rail intravascular ultrasound catheter with a rotating 60 MHz transducer, used in the cath lab to image coronary arteries before and after stenting. It connects to the MDU5 PLUS motor drive and the iLab Polaris (or AVVIGO) guidance system, which display the cross-sectional images. Its distinctive feature is the high-frequency composite transducer that gives fine near-field detail while still imaging to 6 mm depth.
The model
Maker, model and type.
- Maker
- Boston Scientific Corporation
- Model
- OptiCross HD / OptiCross 6 HD 60 MHz coronary imaging catheter with iLab Polaris and MDU5 PLUS
- Device type
- IVUS
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Transducer | 60 MHz composite transducer on a rotating drive cable, radial imaging | Source |
| Maximum diameter penetration | 6 mm | Source |
| Sizes and guide compatibility | 5F (guide ID 0.058 inch or more) and 6F (guide ID 0.064 inch or more) | Source |
| Crossing profile | 3.1F | Source |
| Entry profile | 0.026 inch (5F), 0.017 inch (6F) | Source |
| Guidewire | 0.014 inch | Source |
| Working length | 135 cm | Source |
| Tip to transducer distance | 20 mm (distal marker to transducer 15 mm) | Source |
| Imaging core travel | 15 cm linear movement via the telescoping section, with 1 cm proximal markers | Source |
| Required equipment | iLab Polaris Multi-Modality Guidance System and MDU5 PLUS motor drive; automatic pullback sled optional | Source |
| FDA clearance | 510(k) K213593 (OptiCross and OptiCross HD family) | Source |
Recalls
Known FDA recalls.
- Z-1396-20242024-03-05
Some OptiCross 40 MHz lots made with incorrect voltage setting, possibly dimmer images.
FDA record - Z-0181-20212020-08-24
OptiCross 35 peripheral catheter length markings could flake off.
FDA record - Z-1804-20202019-09-18
iLab Polaris systems upgraded with an earlier 2.10 software had an archiving bug.
FDA record - Z-1487-20142014-04-03
iLab 3.0 software changed default pullback speed, affecting Longview distance measurement.
FDA record
Safety
Safety warnings from the record.
- Do not advance the catheter against resistance or force it through a tight stenosis; if withdrawal meets resistance, check under fluoroscopy and remove the whole system together. Source
- In stented vessels the catheter and guidewire can catch on struts, causing entrapment, tip separation or stent dislocation. Source
- Do not pinch, crush, kink or sharply bend the catheter; an insertion angle above 45 degrees is excessive. Source
- The catheter has no user-serviceable parts and must only be connected to the designated systems. Source
Sources
Where this note comes from.
- Boston Scientific, OptiCross HD product page (EU)
- Boston Scientific, OptiCross HD brochure IC-546709-AA (US)
- FDA 510(k) summary K213593
- openFDA recall search, OptiCross
- openFDA recall search, iLab
- openFDA MAUDE problem counts, OptiCross
Not covered: No public iLab Polaris operator or service manual was found, so system error messages, pullback speeds and MDU5 PLUS service checks are missing. MAUDE counts for the OptiCross brand mix 40 MHz, HD and peripheral catheters.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
IVUS