ProGuide™ 00884450697948Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450697948), received between May 17, 2023 and May 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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. Feb 13, 2026Open, Classified

   16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

   Z-1576-2026 · Root cause: Process control · 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.

• MalfunctionMay 17, 2023Material Puncture/Hole; Material Puncture/Hole

  THE ACCOUNT ALLEGES THAT DURING ECMO PROCEDURE, A CRACK WAS NOTED IN THE VENOUS PORT ALLOWING AIR INTO THE DIALYSIS CATHETER. MINOR BLOOD LOSS WAS ALSO NOTED. THE DEVICE WAS EXCHANGED FOR A NEW ONE WITH NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946569 ↗