Impulse™ H74916599220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729304715), received between Jan 28, 2020 and Oct 27, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2021Contamination; Contamination

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. CONTAMINATION WAS OBSERVED INSIDE THE SEALED POUCH OF A MODEL-6F IMPULSE DIAGNOSTIC CATHETER PRIOR TO USE. NO ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704802 ↗
• MalfunctionNov 10, 2020Deformation Due to Compressive Stress

  ELDERLY MALE WITH HISTORY OF ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE AND HYPERTENSION. WHEN HAVING A HEART CATH, THE CATHETER WAS REMOVED FROM PACKAGED AND NOTED TO BE KINKED WHEN LOADED ONTO THE J WIRE. NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10815802 ↗
• MalfunctionJan 28, 2020Tear, Rip or Hole in Device Packaging; Material Deformation; Tear, Rip or Hole in Device Packaging; Material Deformation

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED A 6F IMPULSE WAS SELECTED FOR DIAGNOSTIC USE. THE BOX ARRIVED DAMAGED AND TORN THROUGH TO DAMAGE THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9636872 ↗