ETHIZIA HSP510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031471214), received between Feb 17, 2026 and Sep 30, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Lack of Effect

  It was reported that a patient underwent an unknown procedure on an unknown date and hemostatic patch was used. During the procedure, the product was breaking apart, and no coagulation could be achieved. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949010 ↗
• MalfunctionMay 1, 2026Use of Device Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND HEMOSTATIC PATCH WAS USED. THE HEALTHCARE PROFESSIONAL IS USING THE HEMOSTATIC PATCH AS A LUNG SEALANT (OFF-LABEL USE). THEY MENTIONED THAT WHEN USES HEMOSTATIC PATCH FOR MINIMALLY INVASIVE SURGERIES THE PRODUCT IS QUITE DIFFICULT TO USE DUE TO THE PRODUCT TEARS. THERE IS A FRAILTY TO THE PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059457 ↗
• MalfunctionMay 1, 2026Use of Device Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND HEMOSTATIC PATCH WAS USED. THE HEALTHCARE PROFESSIONAL IS USING THE HEMOSTATIC PATCH AS A LUNG SEALANT (OFF-LABEL USE). THEY MENTIONED THAT WHEN USES HEMOSTATIC PATCH FOR MINIMALLY INVASIVE SURGERIES THE PRODUCT IS QUITE DIFFICULT TO USE DUE TO THE PRODUCT TEARS. THERE IS A FRAILTY TO THE PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059419 ↗
• MalfunctionFeb 17, 2026Structural Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND HEMOSTATIC PATCH WAS USED. THE SITE HAD A PRECLINICAL LAB ON WEDNESDAY, (B)(6) 2026. ONE PATCH WAS OPENED AND IT WAS MORE PLIABLE/LESS RIGID THAN OTHER PATCHES THEY HAVE USED. THEY ALSO NOTICED SOME DELAMINATION BETWEEN THE LAYERS OF THE PATCH AT THE CORNER. A THE DECISION TO NOT USE THE PATCH AND OPEN A NEW ONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372685 ↗