Impulse™ H74916391021Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729213178), received between Dec 3, 2020 and Jul 10, 2023 — classified as 1 death, 5 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT STERILITY OF THE DEVICE WAS COMPROMISED. AN IMPULSE AND EXPO GUIDE CATHETER DID ARRIVE WITH A DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS ARE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE STERILITY CAN BE COMPROMISED UPON OPENING OF THE DEVICES SINCE THE FRAGMENTS CAN FALL IN. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294968 ↗
• MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN IMPULSE GUIDE CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294474 ↗
• MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN IMPULSE GUIDE CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294386 ↗
• MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN IMPULSE GUIDE CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294112 ↗
• MalfunctionJul 7, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN IMPULSE GUIDE CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278811 ↗
• DeathDec 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. TWO 5FR IMPULSE GUIDE CATHETERS WERE USED IN A DIAGNOSTIC ANGIOGRAM PROCEDURE. DURING THE PROCEDURE, PERFORATION OF THE NON-CORONARY CUSP OCCURRED LEADING TO PATIENT DEATH. IT WAS FURTHER REPORTED THERE WERE NO KNOWN ISSUES WITH THE DEVICE PERFORMANCE DURING THE PROCEDURE. AFTER THE CATHETERS WERE INSERTED, THE PATIENT EXPERIENCED CHEST PAIN AND PULSELESS ELECTRICAL ACTIVITY (PEA) CARDIAC ARREST WITH NO OBVIOUS SIGN OF DISSECTION. CARDIAC TAMPONADE OCCURRED. DISSECTION OF THE CORONARY CUSP WAS CONFIRMED ON CT. THE PHYSICIAN'S TEAM'S OPINION WAS THAT A PERFORATION LIKELY OCCURRED WHEN THE CATHETER WAS INSERTED. EMERGENCY THORACOTOMY WAS PERFORMED AND THE PATIENT WAS CARDIOVASCULARLY STABLE. THERE WAS AN INABILITY TO WEAN OFF THE VENTILATOR AND PATIENT DEATH OCCURRED.

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade; Chest Pain; Death; Vascular Dissection

  MAUDE report 10942568 ↗