AcuNav 10F Ultrasound Catheter 08255790Recalls & 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 04056869001012), received between Nov 26, 2024 and Nov 26, 2024 — classified as 1 malfunction.
1 other recall cover devices cleared under the same FDA submission (K033650, K071234, K170263); they may or may not involve this specific model.
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
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.
MalfunctionNov 26, 2024
ACUNAV 10FR WAS INSERTED AND RETURNED BLURRY IMAGE. DEVICE WAS REMOVED AND REPLACED WITH NEW ACUNAV 10FR AND PROCEDURE CONTINUED AS PLANNED WITH NO HARM NOTED TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20782329 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K033650, K071234, K170263. One submission often covers many models, so check the product and lot details in each record.
- Z-1745-2011 · Mar 20, 2009 · TerminatedSiemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
Other Catheter, ultrasound, intravascular devices
- OptiCross H749518100Boston Scientific Corporation · Catheter, ultrasound, intravascular2 deaths457 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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