FINECROSS 35-1450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350703187), received between Jun 19, 2020 and Apr 23, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionApr 23, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT NUMBER MW (B)(4): "DESCRIBE THE EVENT OR PROBLEM: A PATIENT WENT TO THE CATHETERIZATION LAB FOR A STENT PLACEMENT PROCEDURE. DURING THEIR PROCEDURE, IT WAS DETERMINED THAT THE MICROCATHETER TIP EMBOLIZED TO THE RIGHT UPPER PULMONARY ARTERY AND A WIRE FRAGMENT WAS LEFT ENTRAPPED WITHIN THE CENTRAL PA [PULMONARY ARTERY] STENT STRUTS. THE ANGULATION OF THE STENT IN RELATION TO THE PULMONARY ARTERY AND ACUTE ANGLE MAY HAVE MADE THE CATHETER MORE PRONE TO GETTING STUCK ON THE EDGES OF THE STENT. THE WIRE GOT TANGLED IN THE LARGE AMOUNT OF STENT MATERIAL IN THE PULMONARY ARTERY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: STENT PLACEMENT. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) RELEVANT PRE-EXISTING MEDICAL CONDITIONS: OTHER CHARACTERISTICS OR MEDICAL CONDITIONS: COMPLEX CARDIAC HISTORY." ADDITIONAL INFORMATION WAS RECEIVED ON 07AP2025: THE MEDSUN REPORT STANDS ALONE, NO ADDITIONAL INFORMATION COULD BE SHARED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 21890882 ↗
• InjuryJun 19, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE FINECROSS DEVICE WAS SUCCESSFULLY USED TO CROSS A HEAVILY CALCIFIED SUB-TOTAL OCCLUSION. WHILE RETRACTING THE FINECROSS DEVICE AT THE END OF THE PROCEDURE THE TIP OF THE MICROCATHETER BROKE AND REMAINED IN THE PATIENT. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE BROKEN TIP. THE PROCEDURE OUTCOME WAS A SUCCESS. THERE WAS NO IMPACT TO THE PATIENT'S HEALTH. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10176702 ↗
• InjuryJun 19, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE FINECROSS DEVICE WAS SUCCESSFULLY USED TO CROSS A HEAVILY CALCIFIED SUB-TOTAL OCCLUSION. WHILE RETRACTING THE FINECROSS DEVICE AT THE END OF THE PROCEDURE THE TIP OF THE MICROCATHETER BROKE AND REMAINED IN THE PATIENT. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE BROKEN TIP. THE PROCEDURE OUTCOME WAS A SUCCESS. THERE WAS NO IMPACT TO THE PATIENT'S HEALTH. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10176700 ↗