Expo™ H749085263011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729521518), received between Jan 26, 2024 and Feb 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 reports).

2 FDA recall records name this device's identifier, 2 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 16, 2026.

Recalls naming this device

1. Mar 21, 2024Open, 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-1667-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 21, 2024Open, 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-1668-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED VIA MEDWATCH # MW5150065 THAT A FOREIGN MATERIAL WAS PRESENT ON THE DEVICE. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS NOT ALLOWING THE WIRE TO PASS THROUGH AND THERE WAS A PIECE OF PLASTIC ON THE WIRE WHEN REMOVED FROM THE PACKAGE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740611 ↗
• MalfunctionFeb 19, 2024Fracture; Difficult to Insert; Difficult to Advance; Material Deformation; Fracture; Difficult to Insert; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A MODEL-5F EXPO MULTIPACK 145 (5PKX3) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE EXPO CATHETER MULTIPACK FOUND TO HAVE A STRICTURE IN THE 'L' CATHETER OF MULTIPLE CATHETERS IN THE PACK WHICH MADE THEM DIFFICULT TO FLUSH AND IMPOSSIBLE TO PASS A WIRE. FURTHERMORE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730450 ↗
• MalfunctionJan 26, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE CATHETER WAS BEING FLUSHED PRIOR TO INSERTION INTO THE PATIENT, A PIECE OF PLASTIC CAME OUT ON THE WIRE BEFORE ENTERING INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592240 ↗