Opticross
- Recalling firm
- Boston Scientific NZ Ltd
- Product
- OptiCross. [Device]. Model: Material Number: H749518100, H749518120; Material number: H74939352020, H74939352060; Material number: H74939354060, H74939354100; Material number: H7493932700180; Material number: H7493932800350. Also covers: Opticross HD 60 MHz Coronary Imaging Catheter; Opticross 6 HD 60 MHz Coronary Imaging Catheter; OptiCross(TM) 18 30 MHz Peripheral Imaging Catheter; OptiCross 35 15 MHz Peripheral Imaging Catheter
- Reason
- The manufacturer is notifying customers of updated flushing instructions for the OptiCross™ family of intravascular ultrasound (IVUS) imaging catheters, reinforcing device preparation and air-management practices, and advising of forthcoming updates to the Instructions for Use (IFU)., The updated IFU will remove instructions allowing flushing while the catheter is positioned within the patient when entrapped air is suspected and will further clarify device preparation and air-management procedures., The affected catheters remain available for use. Until the revised IFU is issued, users...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-10-22
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/27491409-6f26-45ca-82d2-ca43015280b4