Expo™ H74908526961Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729366775), received between May 28, 2019 and Jul 10, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 21, 2024Class IOpen, Classified

   An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

   Z-1683-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN EXPO CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295093 ↗
• MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN EXPO CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294960 ↗
• MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN EXPO CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294884 ↗
• MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN EXPO CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294783 ↗
• MalfunctionJul 7, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN EXPO GUIDE CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278818 ↗
• MalfunctionMay 28, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN FIBER WAS OBSERVED ON THE DEVICE. A 5F EXPO GUIDE CATHETER WAS SELECTED FOR A DIAGNOSTIC CORONARY ANGIOGRAM. THE DEVICE WAS PREPARED AND FLUSHED USING NORMAL PROCESSES. UPON FURTHER INSPECTION OUTSIDE THE PATIENT PRIOR TO USE, IT WAS NOTED THAT THERE WAS A FIBER ON THE TIP OF THE CATHETER. THE DEVICE WAS NOT USED. A NEW CATHETER WAS OBTAINED AND USED WITHOUT PROBLEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8646802 ↗