SiteSeer™ 6A0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994941213), received between Jul 23, 2020 and Jul 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K932092); 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.

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.

• MalfunctionJul 23, 2020Use of Device Problem; Use of Device Problem

  A SITESEER CARDIVASCULAR DIAGNOSTIC ANGIOGRAPHY CATHETER WAS USED DURING A PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS EXPIRED. THE USED BY DATE WAS THE (B)(6) 2020 AND THE DEVICE WAS USED ON (B)(6) 2020. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932092. One submission often covers many models, so check the product and lot details in each record.

• Z-0523-04 · Jan 14, 2004 · Terminated
  Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029