PerClot PCUS003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05413765891366), received between Dec 6, 2024 and Nov 24, 2025 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT LEAST THREE PATIENTS DEVELOPED ¿AN UNUSUAL INFLAMMATORY RESPONSE¿ DURING UNSPECIFIED THYROID AND PARATHYROID SURGICAL PROCEDURES WITH PERCLOT. FURTHERMORE, BETWEEN POST OPERATIVE DAY TWO AND FOUR EACH PATIENT DEVELOPED ¿REDNESS AROUND THE INCISION¿ WHICH REQUIRED UNSPECIFIED ¿ALLERGY MEDICATION¿ TO TREAT THE ¿POTENTIAL ALLERGIC REACTIONS.¿ NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation

  MAUDE report 23634171 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING AN UNSPECIFIED SURGICAL PROCEDURE PERCLOT WAS APPLIED. AFTER AN UNSPECIFIED AMOUNT OF TIME, ON A POST OPERATIVE IMAGING SCAN, AN INFECTION WAS FOUND IN THE AREA WHERE THE PERCLOT WAS APPLIED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 22439236 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REGARDING A PERCLOT, DURING CERVICAL SPINE SURGERY, A PATIENT WAS RE-OPERATED DUE TO AN ADVERSE REACTION. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22394887 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERCLOT WAS USED DURING TWO PENILE IMPLANT SURGERIES WHERE POST-OPERATIVELY, IT WAS REPORTED THAT BOTH PATIENTS DEVELOPED ¿MASSIVE HAEMATOMAS¿ AND HAD A SIGNIFICANT DRAIN OUTPUT. ONE PATIENT NEEDED TO KEEP THE DRAIN IN FOR FIVE DAYS. DURING THE USE OF THE PERCLOT, THERE WAS NORMAL BLEEDING FOR THESE CASES AND BLEEDING WAS STOPPED AND DRIED UP THE AREA AS EXPECTED BY THE DOCTOR. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 21704113 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WHEREIN PERCLOT WAS APPLIED, AND THE PATIENT DEVELOPED A BOWEL OBSTRUCTION. DURING THE PROCEDURE THE PERCLOT TURNED WHITE; HOWEVER, PER IFU EXCESS UNREACTED PRODUCT SHOULD BE CAREFULLY REMOVED AND IRRIGATED AWAY FROM THE SITE. AFTER AN UNSPECIFIED AMOUNT OF TIME THE PATIENT EXPERIENCED A BOWEL OBSTRUCTION. TO REMEDY THE OBSTRUCTION, A REVISION SURGERY WAS PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20861305 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WHEREIN PERCLOT WAS APPLIED, AND THE PATIENT EXPERIENCED RE-BLEEDING. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND A BLOOD TRANSFUSION WAS ADMINISTERED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20861134 ↗