Expo™ H74908526501Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729249399), received between Sep 12, 2022 and Sep 12, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 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-1671-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-1672-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjurySep 12, 2022Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED VIA USER MEDWATCH MW5111200 THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMI). THE TARGET LESION WAS LOCATED IN THE RIGHT FEMORAL ARTERY. THE 5F EXPO WR (5PK) CATHETER WAS INSERTED INTO THE SHEATH. THE PHYSICIAN WAS HAVING DIFFICULTY ENGAGING THE ARTERY AND HAD TO TWIST THE DEVICE TO GET THE CATHETER ENGAGED. WHEN THEY PANNED OUT TO LOOK AT THE ARTERIES THE CATHETER WAS KINKED RIGHT OUTSIDE THE SHEATH AND INSIDE THE ARTERY. UPON WITHDRAWAL, THE CATHETER WOULD NOT COME OUT. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401968 ↗