VeriSight Intracardiac Echocariography Catheter VSICE2DRecalls & reported problems
Philips Image Guided Therapy Corporation · Class 2
Data updated Oct 18, 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 00845225003029), received between Aug 19, 2025 and Aug 19, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A VERISIGHT CATHETER WAS USED IN A THERAPEUTIC ELECTROPHYSIOLOGY PROCEDURE. DURING INSERTION, RESISTANCE WAS ENCOUNTERED, BUT WAS ABLE TO ADVANCE TO THE LEFT FEMORAL VEIN. HOWEVER, AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A RETROPERITONEAL BLEED, AND A CLOSURE DEVICE WAS USED TO STOP THE BLEEDING. AT THIS POINT, THE PROCEDURE WAS COMPLETED AND THE PATIENT IS DOING WELL. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE VERISIGHT WAS IN USE WHEN A PERFORATION OCCURRED, REQUIRING INTERVENTION.
Patient problems: Perforation of Vessels
MAUDE report 22845802 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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