R2P METACROSS RX BD-P50200ERRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04540778167117), received between Oct 1, 2019 and Oct 24, 2019 — classified as 2 injuries.

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

• InjuryOct 24, 2019Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  THE ACCOUNT WAS ATTEMPTING TO PTA A HEAVILY CALCIFIED SFA WHEN THE BALLOON WOULD NOT ADVANCE FORWARD OR COULD IT BE REMOVED OVER THE WIRE BEFORE IT FRACTURED. AN OPEN SURGICAL FOREIGN BODY RETRIEVAL WAS PERFORMED TO REMOVE THE BALLOON. THE BALLOON WAS REMOVED. THE PATIENT IS STABLE AND RECOVERING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9231315 ↗
• InjuryOct 1, 2019Fracture

  DURING PLANNED ANGIOGRAM AND INTERVENTION BALLOON FRACTURED OFF. ATTEMPTS WERE MADE BY DR (B)(6) TO RETRIEVE THE PRODUCT. UNABLE TO RETRIEVE. CALLED (B)(6). PT TAKEN TO OPERATING ROOM FOR RETRIEVAL OF FOREIGN BODY WITH ADMISSION TO ICU. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9145724 ↗