FemoStop™ GoldRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734050036), received between Oct 17, 2019 and May 12, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE USING A 7F SHEATH. REPORTEDLY, THE KNOT DEPLOYED IN THE TISSUE TRACT AND NOT IN THE VESSEL. MANUAL COMPRESSION WAS APPLIED BUT HEMOSTASIS WAS NOT ACHIEVED. A FEMOSTOP GOLD WAS USED TO ACHIEVE HEMOSTASIS WHICH RESULTED IN A HEMATOMA AND BRUISING AT THE ACCESS SITE. THE SIZE OF THE HEMATOMA IS UNKNOWN. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma

  MAUDE report 25151290 ↗
• MalfunctionMar 31, 2025Inflation Problem; Improper or Incorrect Procedure or Method; Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED WHEN THE FEMOSTOP WAS APPLIED, THE PRESSURE GAUGE DOES NOT WORK AND THE DOME CANNOT INFLATE. THEREFORE, THE FEMOSTOP WAS REPLACED. THE DEVICE WAS USED PAST THE EXPIRATION DATE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734160 ↗
• MalfunctionOct 7, 2024Improper or Incorrect Procedure or Method; Battery Problem; Improper or Incorrect Procedure or Method; Battery Problem

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384114 ↗
• MalfunctionJul 12, 2024Improper or Incorrect Procedure or Method; Component Missing; Improper or Incorrect Procedure or Method; Component Missing

  IT WAS REPORTED THAT THE "STRAP" [BELT] WAS MISSING WHEN OPENING A FEMOSTOP GOLD. ADDITIONALLY, BASED ON THE LOT NUMBER, THE DEVICE WAS USED AFTER EXPIRATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19734162 ↗
• InjuryOct 17, 2019Deflation Problem; Inflation Problem; Device Displays Incorrect Message; Deflation Problem; Inflation Problem; Device Displays Incorrect Message

  DURING THE PROCEDURE, THE PATIENT EXPERIENCED BRADYCARDIA. WHEN ATTEMPTING TO DEFLATE THE DOME, NO PRESSURE OR AIR WOULD RELEASE. THE DIGITAL MANOMETER READ 73 BUT THE DOME APPEARED FULLY INFLATED. THE DOME WAS MANUALLY PRESSED WHICH DEFLATED THE DOME. THE DOME WAS ATTEMPTED TO BE RE-INFLATED, BUT IT WOULD NOT EASILY RE-INFLATE. EVENTUALLY THE DOME DID RE-INFLATE BUT THE MANOMETER STILL DID NOT APPEAR TO BE WORKING CORRECTLY. THE PATIENT WAS BRADYCARDIC, ATROPINE WAS ADMINISTERED BUT INEFFECTIVE. SHORTLY AFTER THE AIR IN THE DOME WAS RELEASED, THE PATIENT'S HEART RATE RETURNED TO BASELINE. THERE WAS NO PATIENT HARM.

  Patient problems: Bradycardia

  MAUDE report 9203875 ↗