Empira™ NC RX PTCA Dilatation Catheter 75R10325NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812917020848), received between Feb 9, 2018 and Feb 9, 2018 — classified as 1 malfunction.

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

• MalfunctionFeb 9, 2018Break; Burst Container or Vessel; Break; Burst Container or Vessel

  INITIAL COMPLAINT DESCRIPTION RECEIVED ON 15-JAN-2018 IS AS FOLLOWS: "DR. (B)(6) WAS DOING A PCI WHEN THE EMPIRA NC BALLOON RUPTURED DURING POST-DILATATION. THE CATHETER SHAFT ALSO BROKE INTO TWO PIECES AS IT WAS BEING PULLED OUT SO A SNARE HAD TO BE USED TO REMOVE THE DISTAL PORTION THAT WAS DISCONNECTED FROM THE PROXIMAL SHAFT. THE DEVICE IS AVAILABLE TO BE SENT BACK FOR INVESTIGATION."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7260407 ↗