Halyard 77769Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651777697), received between Feb 20, 2026 and Feb 20, 2026 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K083234); 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.

• MalfunctionFeb 20, 2026Contamination

  A 62-YEAR-OLD PATIENT WAS ADMITTED FOR CREATION OF A RIGHT-WRIST RADIOCEPHALIC ARTERIOVENOUS FISTULA. DURING THE PROCEDURE, FOREIGN MATERIAL WAS OBSERVED CONTAMINATING THE STERILE FIELD, PRESENTING A POTENTIAL CONTAMINATION RISK. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401963 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083234. One submission often covers many models, so check the product and lot details in each record.

• Z-2520-2025 · Jul 17, 2025 · Open, Classified
  Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
• Z-0983-2025 · Nov 26, 2024 · Open, Classified
  Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A