METACROSS RX BD-L70200CRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04540778153110), received between Mar 4, 2019 and Mar 4, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2019Material Separation; Use of Device Problem; Device Handling Problem; Material Separation; Use of Device Problem; Device Handling Problem

  IN-STENT RESTENOSIS (OCCLUSION) LESION. USING A GUIDING SHEATH AND A 0.014 INCH GUIDE WIRE, AFTER THE CATHETER PASSED THROUGH THE LESION THE BALLOON WAS DILATED, BUT IT WAS RUPTURED AT 14 ATM. THE CHILD CATHETER (THE CATHETER THINNER THAN THE GUIDING SHEATH) COULD BE PLACED IN THE GUIDING SHEATH. BECAUSE THE BALLOON OF THE CATHETER WAS A LITTLE INFLATED, IT ATTEMPTED TO RETRACT INTO THE CHILD CATHETER TO DEFLATE THE BALLOON, BUT IT COULD NOT BE DONE. ULTIMATELY, THE DISTAL END OF THE BALLOON BROKE, AND THE BROKEN FRAGMENT REMAINED IN THE PATIENT'S VESSEL. THE FRAGMENT WAS FIXED TO THE VESSEL WALL WITH THE STENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8388929 ↗