NAVICROSS NC18151Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04987892077319), received between May 10, 2021 and Sep 27, 2024 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionSep 27, 2024

  TIP OF CATHETER PEELED OFF OUTSIDE OF PT. INCIDENT REPORTED, CREDIT ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321179 ↗
• InjuryApr 13, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS PERFORMING AN INTERVENTION IN THE PATIENT. HE BALLOONED AND PULLED BACK THEN WENT DOWN THE AT. THE NAVICROSS WAS USED IN CONJUNCTION WITH A V18. AT THAT POINT THE DISTAL TIP OF THE NAVICROSS BROKE OFF AND WEDGED IN A SIDE BRANCH. THE DOCTOR DECIDED NOT TO RISK RETRIEVING IT AS THERE WAS STILL FLOW TO THE FOOT. THERE WAS NO INJURY TO THE PATIENT. THEIR HYPOTHESIS WAS THAT THE NAVICROSS HIT A PIECE OF CALCIUM UPON PULLING BACK. TYPE OF PROCEDURE PERFORMED WAS A CATHETERIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 15MAR2024: THE BROKEN PIECE IS STILL IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 19MAR2024: OTHER THAN THE REPORTED ISSUE IT WAS A STRAIGHTFORWARD CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19102831 ↗
• InjuryApr 13, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS PERFORMING AN INTERVENTION IN THE PATIENT. HE BALLOONED AND PULLED BACK THEN WENT DOWN THE AT. THE NAVICROSS WAS USED IN CONJUNCTION WITH A V18. AT THAT POINT THE DISTAL TIP OF THE NAVICROSS BROKE OFF AND WEDGED IN A SIDE BRANCH. THE DOCTOR DECIDED NOT TO RISK RETRIEVING IT AS THERE WAS STILL FLOW TO THE FOOT. THERE WAS NO INJURY TO THE PATIENT. THEIR HYPOTHESIS WAS THAT THE NAVICROSS HIT A PIECE OF CALCIUM UPON PULLING BACK. TYPE OF PROCEDURE PERFORMED WAS A CATHETERIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 15MAR2024: THE BROKEN PIECE IS STILL IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 19MAR2024: OTHER THAN THE REPORTED ISSUE IT WAS A STRAIGHTFORWARD CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19102828 ↗
• MalfunctionNov 22, 2023Material Frayed; Material Frayed

  THE USER FACILITY REPORTED THAT OUT OF THE PACKAGE, THE NAVICROSS APPEARED TO BE FRAYED. THE PRODUCT DID NOT ENCOUNTER THE PATIENT. THE CASE WAS A PERIPHERAL SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION. A NEW NAVICROSS WAS USED. NO PATIENT INJURY WAS REPORTED. THE TYPE OF PROCEDURE PERFORMED WAS A PERIPHERAL INTERVENTION. THE ESTIMATED BLOOD LOSS WAS NONE. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE PRODUCT INVOLVED. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194291 ↗
• MalfunctionJan 2, 2023Material Puncture/Hole; Material Puncture/Hole

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS TREATING A TIGHT LESION IN A VERY TORTUOUS RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). NAVICROSS WAS PLACED THROUGH A 45CM DESTINATION SHEATH OVER A COMMAND .018 WIRE. THE COMMAND WIRE WAS EXCHANGED FOR AN .018 STEEL CORE WIRE, WHICH WOULD NOT ADVANCE THROUGH THE END OF THE NAVICROSS CATHETER. THE STEEL CORE WIRE WAS REMOVED, AND THE .018 COMMAND WIRE WAS RE-INSERTED INTO THE NAVICROSS, HOWEVER, APPEARED TO BE EXITING THE SIDE OF THE CATHETER. WHEN THE CATHETER WAS PULLED BACK SLIGHTLY, IT WAS CONFIRMED THAT THE TIP OF THE WIRE WAS MOVING WITH THE CATHETER. BOTH THE .018 NAVICROSS CATHETER AND THE WIRE WERE REMOVED FROM THE BODY AND WHEN THE CATHETER WAS FLUSHED, IT APPEARED TO HAVE A SIDE HOLE. A NEW CATHETER WAS OPENED, AND THE CASE WAS COMPLETED SUCCESSFULLY. THE ESTIMATED BLOOD WAS LESS THAN 250CC. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16084255 ↗
• InjuryNov 28, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE INVOLVED NAVICROSS BROKE OFF IN THE PATIENT. DOCTOR STATED THAT THE PATIENT WAS OK. THE EVENT OCCURRED INTA-OPERATIVE. THE PROCEDURE OUTCOME WAS COMPLETED. THE PATIENT WAS NOT INJURED, AND SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022 : PROCEDURE TAKING PLACE, WHEN THE TIP OF THE NAVICROSS BROKE OFF INSIDE THE PATIENT WAS PAD BELOW THE KNEE CASE. THE NAVICROSS BROKE OFF BELOW THE KNEE AND WERE ABLE TO REMOVE THE NAVICROSS TIP FROM THE PATIENT'S ANATOMY. SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO TORTUOUS ANATOMY EXPERIENCED DURING THE PROCEDURE. THE ORIGINAL PROCEDURE WAS COMPLETED AS INTENDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15867843 ↗
• InjuryNov 28, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE INVOLVED NAVICROSS BROKE OFF IN THE PATIENT. DOCTOR STATED THAT THE PATIENT WAS OK. THE EVENT OCCURRED INTA-OPERATIVE. THE PROCEDURE OUTCOME WAS COMPLETED. THE PATIENT WAS NOT INJURED, AND SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 10 NOV 2022: PROCEDURE TAKING PLACE, WHEN THE TIP OF THE NAVICROSS BROKE OFF INSIDE THE PATIENT WAS PAD BELOW THE KNEE CASE. THE NAVICROSS BROKE OFF BELOW THE KNEE AND WERE ABLE TO REMOVE THE NAVICROSS TIP FROM THE PATIENT'S ANATOMY. SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO TORTUOUS ANATOMY EXPERIENCED DURING THE PROCEDURE. THE ORIGINAL PROCEDURE WAS COMPLETED AS INTENDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15867835 ↗
• MalfunctionOct 28, 2022Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 8 NOV 2022: THE PROCEDURE PERFORMED WAS A RUNOFF PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE DEVICE DID NOT APPEAR DAMAGED PRIOR TO USE. THE PIECES BROKE OFF INSIDE THE PATIENT AND WERE NOT RETRIEVED. THE CATHETER TIP WAS LEFT INSIDE THE PATIENT. THE PATIENT WAS IN STABLE CONDITION. THE BLOOD LOSS WAS 20CC'S.

  Patient problems: Foreign Body In Patient

  MAUDE report 15691416 ↗
• MalfunctionMay 10, 2021Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED IT WAS A CRITICAL LIMB ISCHEMIA CASE. ACCESS WAS GAINED IN THE LEFT GROIN FOR TREATMENT OF THE RIGHT LEG. THE TARGET LESION STARTED IN THE SFA AND PERFUSE DISEASE CONTINUED THROUGHOUT THE INFRAPOP REGION. WIRE ACCESS WAS OBTAINED USING AN 018 GWA. THE PROCEDURE TOOK MUCH TIME AND THE EQUIPMENT WAS IN THE BODY FOR AN EXTENDED PERIOD OF TIME; THE EXACT TIME IS NOT KNOWN. SUCCESSFUL CROSSING OF THE LESION WAS COMPLETED USING THE GWA AND NAVICROSS COMBINATION. AFTER CROSSING, AND MULTIPLE ANGIOGRAMS OF THE VESSELS, THE PHYSICIAN ATTEMPTED A WIRE EXCHANGE THROUGH THE NAVICROSS. IT WAS THEN THAT THE PHYSICIAN HAD NOTICEABLE RESISTANCE. HE THEN TRIED TO REMOVE THE CATHETER WHILE LEAVING THE WIRE IN PLACE AND WAS UNABLE TO COMPLETE THE ACTION. IT APPEARED AS IF THE CATHETER HAD BECOME FUSED TO THE WIRE. HE TRIED PULLING HARDER AND THE CATHETER HUB BROKE FREE FROM THE REST OF THE CATHETER. HE THEN PULLED ON THE CATHETER AGAIN AND A SECOND PIECE BROKE. AT THIS POINT HE HAD DECIDED TO REMOVE BOTH WIRE AND REMAINING PIECE OF THE FUSED CATHETER. THERE WAS NO PATIENT HARM DURING THIS EVENT. THE CASE WAS A SUCCESS AND PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796622 ↗