Bridge™ Prep Kit 00884450771310Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450771310), received between Feb 20, 2025 and Feb 20, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 2, 2026Open, Classified

   catheter may experience resistance when being advanced over the guidewire

   Z-2002-2026 · Root cause: Nonconforming Material/Component · 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.

• InjuryFeb 20, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT A BRIDGE GUIDE WIRE FROM ONE OF THE PREP KITS BROKE APART INSIDE THE PATIENT. THE TIP OF THE WIRE GOT STUCK IN THE IVC AND WHEN THE EP EXTRACTOR PULLED BACK THE GUIDE WIRE IT SLINKIED APART. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY SNARE THE PIECE THAT BROKE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 21420479 ↗