FLIXENE 25053Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00650862250534), received between Jan 7, 2026 and Jan 7, 2026 — classified as 1 malfunction.

18 other recalls cover devices cleared under the same FDA submission (K060124, K231972); 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.

• MalfunctionJan 7, 2026Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987547 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060124, K231972. One submission often covers many models, so check the product and lot details in each record.

• Z-2005-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
• Z-2013-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
• Z-2006-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
• Z-2012-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
• Z-2009-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
• Z-2004-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
• Z-2011-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
• Z-2018-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
• Z-2017-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
• Z-2007-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
• Z-2008-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
• Z-2015-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
• Z-2003-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
• Z-2014-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
• Z-2016-2024 · May 3, 2024 · Open, Classified
  FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

…and 3 more.