NAVICROSS NC35131Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04987350709202), received between Feb 14, 2017 and Mar 2, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING A PERI-VALVULAR LEAK CASE, THE NAVICROSS WAS PUSHED THROUGH THE LEAK, BEHIND THE VALVE AND INTO THE LEFT VENTRICLE. THE WIRE WAS EXCHANGED FOR A SAFARI WIRE. THE NAVICROSS WAS PULLED TO BE REMOVED FROM THE BODY. THERE WAS SOME DIFFICULTY PULLING THE NAVICROSS OUT. AFTER REMOVAL IT WAS NOTICED THAT A MARKER BAND WAS LEFT ON THE WIRE. ATTEMPTS TO SNARE IT OUT WERE MADE. EVENTUALLY THE MARKER BAND ENDED UP IN THE VENTRICLE BEHIND SOME PAPILLARY MUSCLE. THE PATIENT WILL BE BROUGHT BACK IN A FEW WEEKS TO ATTEMPT CLOSURE OF PERIVAVULAR LEAK AGAIN. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 04FEB2026: SL: THE PATIENT WAS STABLE, AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24492481 ↗
• InjuryMar 2, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING A PERI-VALVULAR LEAK CASE, THE NAVICROSS WAS PUSHED THROUGH THE LEAK, BEHIND THE VALVE AND INTO THE LEFT VENTRICLE. THE WIRE WAS EXCHANGED FOR A SAFARI WIRE. THE NAVICROSS WAS PULLED TO BE REMOVED FROM THE BODY. THERE WAS SOME DIFFICULTY PULLING THE NAVICROSS OUT. AFTER REMOVAL, IT WAS NOTICED THAT A MARKER BAND WAS LEFT ON THE WIRE. ATTEMPTS TO SNARE IT OUT WERE MADE. EVENTUALLY THE MARKER BAND ENDED UP IN THE VENTRICLE BEHIND SOME PAPILLARY MUSCLE. THE PATIENT WILL BE BROUGHT BACK IN A FEW WEEKS TO ATTEMPT CLOSURE OF PERIVAVULAR LEAK AGAIN. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 04FEB2026:SL: THE PATIENT WAS STABLE, AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24492480 ↗
• InjuryNov 26, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: A VASCULAR SURGEON WAS DOING A PERIPHERAL CASE. GROIN ACCESS AND SHEATH WAS UP AND OVER. THE NAVICROSS 035 WAS DOWN LEG AND THERE WAS A 035 GLIDEWIRE ADVANTAGE IN THE NAVICROSS 035. THE DOCTOR WAS TRYING TO TAKE THE NAVICROSS OUT OVER THE WIRE AND IT WAS HARD TO REMOVE. THE DOCTOR HELD ON TO THE PORT OF THE NAVICROSS AND IT PULLED OFF. THEN HE GOT THE HEMOSTATS AND TRIED TO PULL THE NAVICROSS OUT AND THAT PIECE BROKE OFF. HE PULLED AGAIN AND THE REST OF THE NAVICROSS CAME OUT. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NAVICROSS BROKE INSIDE THE PATIENT. ALL OF THE CATHETER WAS RETRIEVED BY ADVANCING A SHEATH DILATOR TO PUSH OUT THE BROKEN PIECE OF THE NAVICROSS THROUGH A PEDAL SHEATH. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23655663 ↗
• InjuryNov 26, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: A VASCULAR SURGEON WAS DOING A PERIPHERAL CASE. GROIN ACCESS AND SHEATH WAS UP AND OVER. THE NAVICROSS 035 WAS DOWN LEG AND THERE WAS A 035 GLIDEWIRE ADVANTAGE IN THE NAVICROSS 035. THE DOCTOR WAS TRYING TO TAKE THE NAVICROSS OUT OVER THE WIRE AND IT WAS HARD TO REMOVE. THE DOCTOR HELD ON TO THE PORT OF THE NAVICROSS AND IT PULLED OFF. THEN HE GOT THE HEMOSTATS AND TRIED TO PULL THE NAVICROSS OUT AND THAT PIECE BROKE OFF. HE PULLED AGAIN AND THE REST OF THE NAVICROSS CAME OUT. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NAVICROSS BROKE INSIDE THE PATIENT. ALL OF THE CATHETER WAS RETRIEVED BY ADVANCING A SHEATH DILATOR TO PUSH OUT THE BROKEN PIECE OF THE NAVICROSS THROUGH A PEDAL SHEATH. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23655661 ↗
• InjuryOct 8, 2024Migration; Migration

  THE USER FACILITY REPORTED THAT THE METAL RADIOPAQUE MARKER FROM THE DEVICE WAS STUCK ON THE PATIENT'S TAVR VALVE STRUT AND GOT DISLODGED FROM THE CATHETER WHEN REMOVED. THE MARKER FLOATED AWAY FROM THE INITIAL POSITION AND ENDED UP LODGED IN THE DISTAL PORTION OF THE CIRCUMFLEX CORONARY ARTERY. IMMEDIATE ACTIONS REPORTED WAS A LEFT HEART CAUTERIZATION (LHC) PERFORMED TO IDENTIFY THE AREA WHERE IT IS WAS LODGED AND POSSIBLE COMPLICATIONS DEPARTMENT REVIEWER COMMENTS / ACTIONS PATIENT WAS HAVING A PARAVALVULAR LEAK CLOSURE PROCEDURE AND DURING THE CASE, A CATHETER MARKER FROM A NAVICROSS CATHETER DISLODGED. A LEFT HEART CATHETERIZATION WAS PERFORMED TO CHECK FOR POSITION OF DISLODGED PART ON FLUOROSCOPY. THE MARKER WAS NOTED TO BE LODGED IN THE DISTAL CIRCUMFLEX AND IN STABLE POSITION WITH NO CURRENT HARM AT THE TIME AND GOOD BLOOD FLOW WAS NOTED. THE PATIENT WAS STABLE DURING THE PROCEDURE AND TRANSFERRED OUT OF HYBRID OPERATING ROOM (OR) TO POST-ANESTHESIA CARE UNIT (PACU) IN STABLE CONDITION AFTER SUCCESSFUL PVL CLOSURE PROCEDURE. THE MARKER ENDED UP IN THE CAROTID OF THE PATIENT. THEY WERE ABLE TO GET THE MARKER AND SAVE THE PATIENT. NO BLOOD LOSS WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20397822 ↗
• InjuryOct 8, 2024Migration; Migration

  THE USER FACILITY REPORTED THAT THE METAL RADIOPAQUE MARKER FROM THE DEVICE WAS STUCK ON THE PATIENT'S TAVR VALVE STRUT AND GOT DISLODGED FROM THE CATHETER WHEN REMOVED. THE MARKER FLOATED AWAY FROM THE INITIAL POSITION AND ENDED UP LODGED IN THE DISTAL PORTION OF THE CIRCUMFLEX CORONARY ARTERY. IMMEDIATE ACTIONS REPORTED WAS A LEFT HEART CAUTERIZATION (LHC) PERFORMED TO IDENTIFY THE AREA WHERE IT IS WAS LODGED AND POSSIBLE COMPLICATIONS DEPARTMENT REVIEWER COMMENTS / ACTIONS PATIENT WAS HAVING A PARAVALVULAR LEAK CLOSURE PROCEDURE AND DURING THE CASE, A CATHETER MARKER FROM A NAVICROSS CATHETER DISLODGED. A LEFT HEART CATHETERIZATION WAS PERFORMED TO CHECK FOR POSITION OF DISLODGED PART ON FLUOROSCOPY. THE MARKER WAS NOTED TO BE LODGED IN THE DISTAL CIRCUMFLEX AND IN STABLE POSITION WITH NO CURRENT HARM AT THE TIME AND GOOD BLOOD FLOW WAS NOTED. THE PATIENT WAS STABLE DURING THE PROCEDURE AND TRANSFERRED OUT OF HYBRID OPERATING ROOM (OR) TO POST-ANESTHESIA CARE UNIT (PACU) IN STABLE CONDITION AFTER SUCCESSFUL PVL CLOSURE PROCEDURE. THE MARKER ENDED UP IN THE CAROTID OF THE PATIENT. THEY WERE ABLE TO GET THE MARKER AND SAVE THE PATIENT. NO BLOOD LOSS WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20397661 ↗
• InjuryAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DOCTOR PERFORMED AN INTERVENTION AND ANGIOPLASTY ON THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL, AND TIBIAL ARTERIES. THERE WAS A VERY TIGHT LESION THAT PRESENTED DIFFICULTIES IN CROSSING, AND SHE USED THE .035X135 ANGLED NAVICROSS AGGRESSIVELY, ALONG WITH VARIOUS WIRES. THE DISTAL RADIOPAQUE MARKER OF THE NAVICROSS DETACHED FROM THE CATHETER AND LODGED IN THE DISTAL ANTERIOR TIBIAL ARTERY. THIS DID NOT OBSTRUCT BLOOD FLOW, AND THE PHYSICIAN DECIDED NOT TO REMOVE IT. THE PROCEDURE PERFORMED WAS A RIGHT LEG PERIPHERAL ARTERIAL DISEASE (PAD) INTERVENTION, WITH NO BLOOD LOSS REPORTED. THE INCIDENT OCCURRED INTRA-OPERATIVE. THE REPORTED INCIDENT DID NOT RESULT IN PATIENT INJURY OR MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20058007 ↗
• InjuryAug 23, 2024Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DOCTOR PERFORMED AN INTERVENTION AND ANGIOPLASTY ON THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL, AND TIBIAL ARTERIES. THERE WAS A VERY TIGHT LESION THAT PRESENTED DIFFICULTIES IN CROSSING, AND SHE USED THE .035X135 ANGLED NAVICROSS AGGRESSIVELY, ALONG WITH VARIOUS WIRES. THE DISTAL RADIOPAQUE MARKER OF THE NAVICROSS DETACHED FROM THE CATHETER AND LODGED IN THE DISTAL ANTERIOR TIBIAL ARTERY. THIS DID NOT OBSTRUCT BLOOD FLOW, AND THE PHYSICIAN DECIDED NOT TO REMOVE IT. THE PROCEDURE PERFORMED WAS A RIGHT LEG PERIPHERAL ARTERIAL DISEASE (PAD) INTERVENTION, WITH NO BLOOD LOSS REPORTED. THE INCIDENT OCCURRED INTRA-OPERATIVE. THE REPORTED INCIDENT DID NOT RESULT IN PATIENT INJURY OR MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20056137 ↗
• InjuryFeb 14, 2017Material Separation; Material Separation

  THE TERUMO MEDICAL FACILITY RECEIVED A MEDWATCH REPORT NUMBER MW5067375 ON FEBRUARY 3, 2017. THE USER FACILITY REPORTED THAT THE TIP OF THE NAVICROSS DEVICE BROKE OFF DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING A COMMON FEMORAL INTERVENTION THE TIP OF THE NAVICROSS BROKE OFF INSIDE OF THE VESSEL; IT WAS REPORTED THAT THE VESSEL WAS VERY CALCIFIED AND THE NAVICROSS BECAME STUCK; UPON REMOVAL OF THE DEVICE IT WAS NOTICED THAT THE TIP BROKE OFF; THE CATHETER WAS REMOVED BUT THE TIP REMAINED IN THE PATIENT; THE PROCEDURE WAS COMPLETED; AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGICAL REMOVAL OF THE NAVICROSS TIP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6329941 ↗