OptiCross 6 H7495181060Recalls & reported problems
Boston Scientific Corporation · Coronary Imaging Catheter · Class 2
All models of OptiCross 6 (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729904755), received between Sep 4, 2024 and Sep 4, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT PRESENTED FOR A HIGH RISK, CHRONIC TOTAL OCCLUSION PERCUTANEOUS CORONARY INTERVENTION IN A SAPHENOUS VEIN GRAFT TO CIRCUMFLEX AND A CHRONIC TOTAL OCCLUSION IN THE OBTUSE MARGINAL BRANCH. POST STENTING, THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION. THE PHYSICIAN THINKS THE TIP OF THE CATHETER CAUGHT A PIECE OF PLAQUE AND WHEN THE DEVICE WAS REMOVED WITH DIFFICULTY, BY PULLING, THE CATHETER DISSECTED THE LEFT MAIN. THE DISSECTION WAS STENTED OVER. THE PATIENT WAS FINE AND FULLY RECOVERED.
Patient problems: Vascular Dissection
MAUDE report 20138572 ↗
Other Catheter, ultrasound, intravascular devices
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- OptiCross™ HD H74939352030Boston Scientific Corporation · Catheter, ultrasound, intravascular1 death436 reports
- ViewFlex™ D087031Irvine Biomedical, Inc. · Catheter, ultrasound, intravascular3 deaths341 reports
- OptiCross 18 H7493932800180Boston Scientific Corporation · Catheter, ultrasound, intravascular186 reports
- OptiCross™ 6 HD H74939354080Boston Scientific Corporation · Catheter, ultrasound, intravascular4 deaths177 reports
- Visions PV .014P RX Digital IVUS Catheter 014RPhilips Image Guided Therapy Corporation · Catheter, Ultrasound, Intravascular1 recall1 death84 reports
- Visions PV .018 Digital IVUS Catheter 86700Philips Image Guided Therapy Corporation · Catheter, Ultrasound, Intravascular1 recall67 reports
- OptiCross™ HD H74939352040Boston Scientific Corporation · Catheter, ultrasound, intravascular3 deaths116 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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