FLOSEAL HEMOSTATIC MATRIX ADS201845Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412639604), received between Oct 6, 2020 and Jul 20, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2021Break; Break

  IT WAS REPORTED THAT WHILE PERFORMING AN UNSPECIFIED SURGERY WITH TWO UNITS OF FLOSEAL, THE APPLICATORS REPORTEDLY BROKE AND ¿LACERATED THE SURGEON'S HAND¿. AT THE TIME OF THIS REPORT NO FURTHER DETAIL WAS PROVIDED REGARDING TREATMENT, INTERVENTIONS FOR THE EVENT OR THE SURGEON¿S OUTCOME. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 12198381 ↗
• MalfunctionOct 6, 2020Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT A FLOSEAL FASTPREP KIT WAS MISSING THE STERILE PACKAGING. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO DAMAGE TO THE PACKAGE OR SHIPPING MATERIALS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10638323 ↗

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