BioGlue Surgical Adhesive BG3510-5-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00877234000256), received between Oct 9, 2017 and Oct 9, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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.

• InjuryOct 9, 2017Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  PATIENT'S WIFE CALLED ON 09/14/2017 TO STATE HER HUSBAND HAD BRANCH ARCH REPLACEMENT SURGERY ON (B)(6) 2017. SUFFERED FROM A STROKE ON (B)(6) 2017, A THROMBECTOMY WAS PERFORMED BY NEUROSURGEON [DOCTOR] TO REMOVE THE CLOT. THE MATERIAL THAT WAS REMOVED FROM THE BRAIN APPEARED TO BE FOREIGN. ACCORDING TO THE WIFE A PATHOLOGY REPORT WAS DONE ON THE FOREIGN MATERIAL WHICH WAS ALLEGED TO BE BIOGLUE. THE CURRENT STATUS OF THE PATIENT IS HOSPITALIZED WITH VENTILATION. THE PATIENT WAS TRANSFERRED FROM CARDIAC ICU ON HEMICRANIECTOMY WATCH, MOVED TO NEURO ICU AND IS NOW BACK IN CARDIAC ICU. THE PATIENT HAD A HIGH RISK TOTAL ARCH REPLACEMENT FOR DISSECTION. PER THE SURGEON, BIOGLUE WAS TOPICALLY APPLIED TO EACH ANASTOMOSIS ACCORDING TO THE INSTRUCTIONS FOR USE. HE WOKE UP AFTER SURGERY WITH RIGHT SIDED WEAKNESS. HE WAS SENT FOR NEURO-INTERVENTION AND A SMALL PIECE OF BIOGLUE WAS ALLEGEDLY RETRIEVED FROM A BRANCH OF HIS MCA. HE HAS RESIDUAL WEAKNESS. HE WILL SURVIVE BUT WITH SOME NEUROLOGIC DEFICIT.

  Patient problems: Stroke/CVA

  MAUDE report 6928124 ↗

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