ADVANTA 21000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00650862210002), received between Sep 12, 2026 and Sep 12, 2026 — classified as 1 injury.

39 other recalls cover devices cleared under the same FDA submission (K231972, K992960); 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.

• InjurySep 12, 2026No Apparent Adverse Event

  Patient problems: Bacterial Infection

  MAUDE report 50745765 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K231972, K992960. One submission often covers many models, so check the product and lot details in each record.

• Z-1979-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1974-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1959-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
• Z-1984-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1992-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft
• Z-1987-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1978-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1957-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
• Z-1982-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1986-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1955-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
• Z-1983-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1966-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
• Z-1988-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
• Z-1975-2024 · May 3, 2024 · Open, Classified
  ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

…and 24 more.