FLOSEAL HEMOSTATIC MATRIX ADS202105Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412827957), received between Jan 17, 2025 and Jan 17, 2025 — classified as 3 injuries.

3 other recalls cover devices cleared under the same FDA submission (P990009); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LOWER SPINAL PROCEDURE WITH ¿HARDWARE IMPLANTED¿ (WITH ¿TRIPS BACK TO THE OPERATING ROOM FOR HARDWARE REPLACEMENT) WHEREIN FLOSEAL HEMOSTATIC MATRIX WAS APPLIED. THE PATIENT RECEIVED UNSPECIFIED PRE AND POST OPERATIVE ANTIBIOTICS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY ISSUES WITH FOLLOW UP CARE WITH THE PHYSICIAN. APPROXIMATELY SIX TO EIGHT WEEKS POST OPERATIVELY, THE PATIENT VISITED THE PHYSICIAN, AND THE ¿SOURCE OF SURGERY¿ WAS NOTED TO BE INFECTED. BLOOD CULTURES WERE PERFORMED AND WERE POSITIVE FOR CANDIDA ALBICANS. IT WAS NOT REPORTED WHAT FROM OF MEDICAL INTERVENTION WAS PROVIDED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fungal Infection

  MAUDE report 21185857 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LOWER SPINAL PROCEDURE WITH ¿HARDWARE IMPLANTED¿ (WITH ¿TRIPS BACK TO THE OPERATING ROOM FOR HARDWARE REPLACEMENT) WHEREIN FLOSEAL HEMOSTATIC MATRIX WAS APPLIED. THE PATIENT RECEIVED UNSPECIFIED PRE AND POST OPERATIVE ANTIBIOTICS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY ISSUES WITH FOLLOW UP CARE WITH THE PHYSICIAN. APPROXIMATELY SIX TO EIGHT WEEKS POST OPERATIVELY, THE PATIENT VISITED THE PHYSICIAN, AND THE ¿SOURCE OF SURGERY¿ WAS NOTED TO BE INFECTED. BLOOD CULTURES WERE PERFORMED AND WERE POSITIVE FOR CANDIDA ALBICANS. IT WAS NOT REPORTED WHAT FROM OF MEDICAL INTERVENTION WAS PROVIDED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fungal Infection

  MAUDE report 21185856 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LOWER SPINAL PROCEDURE WITH ¿HARDWARE IMPLANTED¿ (WITH ¿TRIPS BACK TO THE OPERATING ROOM FOR HARDWARE REPLACEMENT) WHEREIN FLOSEAL HEMOSTATIC MATRIX WAS APPLIED. THE PATIENT RECEIVED UNSPECIFIED PRE AND POST OPERATIVE ANTIBIOTICS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY ISSUES WITH FOLLOW UP CARE WITH THE PHYSICIAN. APPROXIMATELY SIX TO EIGHT WEEKS POST OPERATIVELY, THE PATIENT VISITED THE PHYSICIAN, AND THE ¿SOURCE OF SURGERY¿ WAS NOTED TO BE INFECTED. BLOOD CULTURES WERE PERFORMED AND WERE POSITIVE FOR CANDIDA ALBICANS. IT WAS NOT REPORTED WHAT FROM OF MEDICAL INTERVENTION WAS PROVIDED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fungal Infection

  MAUDE report 21185815 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990009. One submission often covers many models, so check the product and lot details in each record.

• Z-0667-2024 · Dec 6, 2023 · Open, Classified
  Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
• Z-2957-2018 · May 30, 2018 · Open, Classified
  FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are lab
• Z-2340-2008 · Jul 31, 2008 · Terminated
  FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological) as an adjunct to hem