BioGlue Surgical Adhesive BG3502-5-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00877234000232), received between Mar 28, 2019 and Mar 28, 2019 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (P010003); 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 18, 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.

• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, A POST OPERATIVE INFECTION OCCURRED. ACCORDING TO THE COMPLAINANT, PATIENT IS STILL BEING FOLLOWED AS OF (B)(6) 2019. (B)(6) 2018: CULTURED FOR STAPHYLOCOCCUS AUREUS. ON (B)(6) 2019: LIGHT GROWTH OF ENTEROCOCCUS FAECALIS AND LIGHT GROWTH OF STREPTOCOCCAL A. ADDITIONAL INFORMATION WAS RECEIVED. "THE INFECTION THAT OCCURRED AT OUR FACILITY WAS ON A PATIENT WHO HAD A LUMBAR LAMINECTOMY ON (B)(6) 2018. WE BROUGHT HER BACK TO THE OR [OPERATING ROOM] ON (B)(6) 2018 WHEN IT WAS DISCOVERED THAT SHE HAD A CSF [CEREBROSPINAL FLUID LEAK] LEAK FROM HER INITIAL SURGERY THAT REQUIRED REPAIR. THE [PRODUCT] WAS USED FOR THE SECOND SURGERY, WHEN THE SURGEON PLACED A BLOOD PATCH TO REPAIR THE CSF LEAK.".

  Patient problems: Unspecified Infection

  MAUDE report 8461873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010003. One submission often covers many models, so check the product and lot details in each record.

• Z-0384-2022 · Oct 7, 2021 · Terminated
  BioGlue Surgical Adhesive, Model BG3510-5-G
• Z-2556-2018 · Jun 4, 2018 · Terminated
  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) i
• Z-2623-2017 · May 19, 2017 · Terminated
  BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
• Z-1674-2014 · Apr 25, 2014 · Terminated
  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