VISTA BRITE TIP SM7504Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

2 other recalls cover devices cleared under the same FDA submission (K021593); they may or may not involve this specific model.

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. Feb 7, 2025Open, Classified

   Catheter manufactured at the incorrect length.

   Z-1330-2025 · Root cause: Employee error · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021593. One submission often covers many models, so check the product and lot details in each record.

• Z-1198-2019 · Feb 7, 2019 · Terminated
  Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into
• Z-0434-05 · Dec 7, 2004 · Terminated
  VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.