BioGlue Surgical Adhesive

• • Terminated Z-0384-2022 FDA Class II ·initiated 7 Oct 2021

  Product is not approved for use in the EU and should not have been distributed in the EU.

• • Terminated Z-2556-2018 FDA Class II ·initiated 4 Jun 2018

  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.

• • Terminated Z-2623-2017 FDA Class II ·initiated 19 May 2017

  The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.

• • Terminated Z-1674-2014 FDA Class II ·initiated 25 Apr 2014

  Serum albumin component monomer failed to meet internally established end of shelf-life specification.

Generic Name

Glue, surgical, arteries

PMA Number

P010003 ↗

FDA Product Code

MUQ

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• PhotoFix Decellularized Bovine Pericardium

  Class II

  FDA 510(k) K183635 Active Cleared 14 Feb 2019

• Cryovalve Sg Pulmonary Human Heart Valve (and Conduit) Open recall

  Unclassified

  FDA 510(k) K092021 Active Cleared 25 May 2010

• Cryopatch Sg Pulmonary Hemi-Artery; Trunk; Branch Open recall

  Class II

  FDA 510(k) K091626 Active Cleared 7 Aug 2009

• Perclot Topical

  Unclassified

  FDA 510(k) K132105 Active Cleared 3 Apr 2014

• Cryopatch Sg Pulmonary Human Cardiac Patch

  Class II

  FDA 510(k) K101866 Active Cleared 23 Jul 2010

• Propatch Soft Tissue Repair Matrix

  Class II

  FDA 510(k) K061892 Active Cleared 22 Nov 2006

See all devices from Cryolife, Inc. →

• What specific types of surgical procedures is BioGlue Surgical Adhesive intended to assist with, and where is it applied within the body?

  BioGlue Surgical Adhesive is designed as an adjunct to traditional hemostasis methods like sutures and staples during open surgical repair of large arteries in adults. It is specifically used to achieve a cohesive seal and control bleeding at critical arterial sites such as the aorta, femoral, and carotid arteries. The adhesive is not intended for use in non-arterial procedures or non-open surgical environments.

• Is BioGlue Surgical Adhesive reusable, and how should it be stored to maintain sterility?

  BioGlue Surgical Adhesive is supplied as a sterile, single-use product, meaning each package is intended for one surgical procedure only. To maintain sterility, it must be stored and handled according to standard sterile medical device protocols, ensuring it remains uncontaminated until use in a controlled surgical environment.

• What regulatory pathway was followed for the approval of BioGlue Surgical Adhesive, and what class does it belong to?

  BioGlue Surgical Adhesive was approved through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number P010003. It is classified as a Class III medical device, which requires rigorous pre-market approval due to its role in critical cardiovascular applications where failure could cause serious harm.

• Can BioGlue Surgical Adhesive be used in pediatric patients, or is it limited to adults?

  BioGlue Surgical Adhesive is explicitly approved for use in adult patients only during open surgical repair of large vessels. The manufacturer’s labeling and regulatory approval do not extend its use to pediatric patients, so it should not be used in children.