Expo™ H74908641411Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729367147), received between Mar 12, 2020 and Mar 12, 2020 — classified as 1 malfunction.

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

• MalfunctionMar 12, 2020Material Perforation; Material Perforation

  IT WAS REPORTED THAT GUIDEWIRE PERFORATED THE SHAFT. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERIOR PULMONARY VEIN. A 6F EXPO GUIDE CATHETER AND AN AMPLATZ SUPER STIFF GUIDEWIRE WERE SELECTED FOR USE. THE AMPLATZ SUPER STIFF WAS USED FOR THE TRANSSEPTAL SHEATH TO CROSS THE LEFT ATRIUM. DURING THE PROCEDURE WITH THE EXPO, THE TRANSSEPTAL DILATOR WAS REMOVED AND THE EXPO PIGTAIL WAS ADVANCED OVER THE WIRE MIDWAY UP. ONCE THE PIGTAIL WAS TORQUED AT THE TIP OF THE WIRE, IT WAS SEEN THAT THE WIRE HAD SHEARED INTO TWO PARTS. ONE PART OF THE WIRE WAS PROTRUDING FROM THE SIDEWALL OF THE PIGTAIL AND THE OTHER HAD TILT THROUGH THE DISTAL TIP. THE WIRE AND THE CATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9825742 ↗