FINECROSS M3-1430Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987892058875), received between Feb 18, 2026 and Feb 18, 2026 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Material Separation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE RESIDUAL TIP WAS ATTEMPTED TO BE SNARED OUT; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS LEFT IN BODY, ASSUMED IT WAS BEHIND SOME PAPILLARY MUSCLE. THE PATIENT WAS STABLE. THERE WERE NO ADDITIONAL MEASURES TO REMOVE THE RESIDUAL TIP, IT WAS FOREVER A PART OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24379864 ↗
• InjuryFeb 18, 2026Material Separation

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE DEVICE WAS INSERTED OVER A PILOT 200 THROUGH A CHRONIC TOTAL OCCLUSION (CTO) OF THE LEFT ARTERY DESCENDING (LAD) THAT WAS HEAVILY CALCIFIED. THE LESION WAS TREATED WITH A 1.5 TAKERU BEFORE INSERTION OF THE M3. THE M3 DID NOT MAKE IT ALL THE WAY DOWN THE VESSEL. AFTER MANIPULATION OF THE M3, IT APPEARED THAT A PORTION OF THE TIP OF THE M3 BROKE OFF AND WAS IN THE VESSEL. MULTIPLE MICRO CATHETERS, WIRES, AND BALLOONS WERE USED TO OPEN THE LESION. THE PATIENT WILL BE BROUGHT BACK IN 2-4 WEEKS TO COVER THE TIP WITH A STENT. IT WAS BELIEVED THE TIP IS IN THE SUB INTIMAL SPACE OF THE LAD. THE BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS STABLE. THE DEVICE WAS NOT CONTAMINATED BY INFECTIOUS AGENTS OR ANTI-CANCER AGENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24379862 ↗