Bridge™ Prep Kit 00884450843024Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450843024), received between Jul 22, 2025 and Nov 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

• MalfunctionNov 10, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem

  THE ACCOUNT ALLEGES THE 12F INTRODUCER FELL APART WHILE REMOVING THE DEVICE FROM THE WIRE FROM WITHIN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510632 ↗
• MalfunctionJul 22, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE 12F SHEATH TORE AT THE DISTAL TIP ON A PRE-DILATED PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571918 ↗
• MalfunctionJul 22, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE 12F SHEATH TORE AT THE DISTAL TIP ON A PRE-DILATED PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571916 ↗