NAVICROSS NC18901Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987892077234), received between Oct 15, 2021 and Feb 11, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Material Deformation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: LEFT BELOW THE KNEE (BTK) ANGIOPLASTY. PEDAL ACCESS 6F, .018" 90CM NAVICROSS PLACED OVER A .018 V18 WIRE. THE INNER LINING OF THE NAVICROSS CAME OUT. A NEW NAVICROSS WAS USED TO FINISH THE CASE, THE PATIENT WAS NOT HARMED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317271 ↗
• InjuryOct 15, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF THE .018 NAVICROSS CATHETER BROKE OFF IN THE SUBINTIMAL SPACE. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 27SEPT2021. THE PROCEDURE WAS FOR PERIPHERAL ARTERIAL DISEASE (PAD) / CHRONIC TOTAL OCCLUSION (CTO) IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PIECE WAS LEFT BEHIND IN THE SUBINTIMAL SPACE. SURGICAL INTERVENTION WAS NOT REQUIRED. IT APPEARED TO BE A PIECE OF THE RADIOPAQUE MARKER ON THE DISTAL TIP .018 NAVICROSS CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 12642484 ↗
• InjuryOct 15, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF THE .018 NAVICROSS CATHETER BROKE OFF IN THE SUBINTIMAL SPACE. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 27SEPT2021. THE PROCEDURE WAS FOR PERIPHERAL ARTERIAL DISEASE (PAD) / CHRONIC TOTAL OCCLUSION (CTO) IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PIECE WAS LEFT BEHIND IN THE SUBINTIMAL SPACE. SURGICAL INTERVENTION WAS NOT REQUIRED. IT APPEARED TO BE A PIECE OF THE RADIOPAQUE MARKER ON THE DISTAL TIP .018 NAVICROSS CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 12642464 ↗