Skip to content

Floseal 1505291Recalls & reported problems

Baxter Healthcare Corporation · FLOSEAL Hemostatic Matrix, 10 mL · Class 3 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412532868), received between Feb 6, 2018 and Feb 6, 2018 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 6, 2018Break; Break

    IT WAS REPORTED THAT THE TWO PIECES OF A FLOSEAL SYRINGE BROKE OFF AND INTO A PATIENT DURING SURGERY. THE BROKEN PIECES WERE FROM GRIP OF THE BARREL OF THE SYRINGE AND WERE REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7245452 ↗

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

Other Absorbable collagen hemostatic agent with thrombin devices

All Absorbable collagen hemostatic agent with thrombin devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.