Glue, Surgical, Arteries
FDA adverse event reports and recall history for glue, surgical, arteries (product code MUQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 493
- Deaths
- 45
- Injuries
- 418
- Malfunctions
- 8
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2014-05-30TerminatedProcess control
BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries).
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
- Open, ClassifiedSoftware design
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
- TerminatedNo Marketing Application
BioGlue Surgical Adhesive, Model BG3510-5-G
Product is not approved for use in the EU and should not have been distributed in the EU.
- TerminatedError in labeling
BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
- TerminatedLabeling mix-ups
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
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