Impulse™ H74916391221Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729344834), received between Jul 28, 2020 and Jul 8, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19692379 ↗
• MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691990 ↗
• MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691902 ↗
• MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691900 ↗
• MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691859 ↗
• InjuryJan 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 58-YEAR-OLD MALE PATIENT (WEIGHT: 89 KG) WHO EXPERIENCED ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) (24-HOUR ONSET OF SYMPTOMS) WAS HOSPITALIZED AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PCI WAS PERFORMED VIA RADIAL ACCESS. PRIMARY 3 STENTS WERE PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) (PROXIMAL TO MEDIAL, STENT DES/SYNERGY II), LAD (PROXIMAL, STENT/DES SYNERGY II), AND DIAGONAL BRANCH I (STENT/SYNERGY II). SSO2 THERAPY WAS DELIVERED TO A PATIENT USING THE THEROX DOWNSTREAM CONSOLE (SN (B)(6) WITH BSC IMPULSE CATHETER (LOT #60236430), WHICH WAS INSERTED IN THE RIGHT FEMORAL ARTERY, AND THE SSO2 THERAPY WAS STARTED WITHOUT ANY PROBLEMS. APPROXIMATELY 35 MINUTES AFTER THE INITIATION OF THE SSO2 THERAPY, THE PATIENT EXPERIENCED CHEST/THORACIC PAIN DESPITE 2 MORPHINE DOSES GIVEN TO RELIEVE SAID PAIN. DUE TO PERSISTENT CHEST PAIN, THE SSO2 THERAPY WAS STOPPED, AND AN OPTICAL COHERENCE TOMOGRAPHY (OCT) EXAMINATION WAS CARRIED OUT IMMEDIATELY TO EXAMINE THE STENTS AND VESSEL WALLS IN DETAIL. A DISSECTION WAS NOTED IN THE STENT AREA IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) PROXIMAL AREA. THE PATIENT RECEIVED HEPARIN 1X 5.000IE ANTI-COAGULANT, TICAGRELOR, A

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 13200983 ↗
• MalfunctionJul 28, 2020Difficult to Advance

  ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE AND CHEST PAIN. WHILE HAVING A HEART CATHETERIZATION, THE DEVICE WAS ABLE TO FLUSH BUT THE WIRE WAS UNABLE TO BE THREADED THROUGH. NO KNOWN HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331842 ↗