AcuNav CRYSTAL G Ultrasound Catheter 11657484Recalls & reported problems
Siemens Medical Solutions USA, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869957708), received between Aug 31, 2026 and Aug 31, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533177 ↗
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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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