ADVANTA 21074Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00650862210743), received between Jun 6, 2025 and Jun 6, 2025 — classified as 1 malfunction.

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

15 other recalls cover devices cleared under the same FDA submission (K231972, K992958); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY HOSPITAL THAT AFTER THE ANASTOMOSIS, ABOUT 5 CM FROM THE BACK OF THE GRAFT, A WHITISH YELLOWISH FLUID STARED TO EXUDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K231972, K992958. One submission often covers many models, so check the product and lot details in each record.

• Z-1996-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
• Z-1958-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
• Z-1962-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
• Z-1954-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
• Z-2001-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1997-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
• Z-1999-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
• Z-1993-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
• Z-1994-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
• Z-1995-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
• Z-2000-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1998-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
• Z-1951-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
• Z-1964-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
• Z-2313-2013 · Jul 12, 2013 · Terminated
  Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.