NAVICROSS NC35150Recalls & reported problems
Terumo Corporation · NAVICROSS Support Catheter · Class 2
All models of NAVICROSS (11)
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 04987350709301), received between Aug 14, 2019 and Aug 14, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Most reported problems
Device problems
- Material Deformation1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2019Material Deformation; Material Deformation
THE USER FACILITY REPORTED THAT THE INVOLVED NAVICROSS WAS DAMAGED DURING USE. THERE WERE NO ISSUES WITH THE CONDITION OF THE PATIENT. THE OUTCOME WAS GOOD, A NEW NAVICROSS WAS USED. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC'S. ADDITIONAL INFORMATION WAS RECEIVED ON 05AUG2019. THE PROCEDURE WAS A PERIPHERAL CASE, AND THE DEVICE KINKED DURING USE.
Patient problems: Blood Loss
MAUDE report 8893361 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 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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