PuraStat 621-035Recalls & reported problems
3-D Matrix Europe · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04560436590354), received between Aug 15, 2025 and Nov 14, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Inadequate Pain Relief1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MANUFACTURER RECEIVED A MEDWATCH REPORT DESCRIBING A DEVICE MALFUNCTION DURING PATIENT USE. EVENT DESCRIPTION FROM HEALTH PROFESSIONAL: DESCRIBE THE EVENT OR PROBLEM: PATIENT WAS AN ACTIVE BLEED DURING THE PROCEDURE RECEIVING BLOOD TRANSFUSION. MULTIPLE TYPES OF INTERVENTION WERE DONE AND THE PURA STAT WAS DELAYING CARE. A SECOND SYRINGE OF PURA STAT WAS USED WITHOUT DIFFICULTY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? EGD. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN.
Patient problems: Insufficient Information
MAUDE report 23555783 ↗MalfunctionAug 15, 2025Therapeutic or Diagnostic Output Failure
FROM STAFF: PATIENT WAS AN ACTIVE BLEED DURING THE PROCEDURE RECEIVING BLOOD TRANSFUSION. MULTIPLE TYPES OF INTERVENTION WERE DONE AND THE PURA STAT WAS DELAYING CARE. A SECOND SYRINGE OF PURA STAT WAS USED WITHOUT DIFFICULTY.
Patient problems: Inadequate Pain Relief
MAUDE report 22814265 ↗
Other Hemostatic Device For Endoscopic Gastrointestinal Use devices
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- Hemospray G21049Cook Incorporated · Hemostatic device for endoscopic gastrointestinal use3 recalls1 death83 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.