Impulse™ H74916391411Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729214342), received between Sep 24, 2019 and May 10, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED VIA MEDWATCH 3600840000 THAT A PIN HOLE WAS INSIDE THE CATHETER. THE PATIENT PRESENTED WITH NEW ONSET CHEST PAIN. DURING A RIGHT AND LEFT HEART CATHERIZATION PROCEDURE, THIS IMPULSE GUIDE CATHETER WAS SELECTED; HOWEVER, THE DEVICE HAD A PIN HOLE INSIDE OF THE CATHETER BY THE PORT END. THE DEVICE WAS REMOVED WITHOUT KNOW HARM TO THE PATIENT.

  Patient problems: Chest Pain

  MAUDE report 14346390 ↗
• MalfunctionApr 18, 2022Material Puncture/Hole

  MIDDLE-AGED MALE WITH NEW ONSET OF CHEST PAIN. PROCEDURE: RIGHT AND LEFT HEART CATH. DEVICE HAD A PIN HOLE INSIDE OF THE CATHETER BY THE PORT END. DEVICE REMOVED WITHOUT KNOWN HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, IMPULSE¿ (PER SITE REPORTER): WILL OBTAIN.

  Patient problems: Chest Pain

  MAUDE report 14134874 ↗
• MalfunctionNov 12, 2020Material Twisted/Bent

  ELDERLY FEMALE WITH HISTORY OF SHORTNESS OF BREATH. IN CATH LAB HAVING A HEART CATH, 5F PIG 145 CATHETER KINKED OUT OF PACKAGE, DID NOT ENTER THE BODY. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10828596 ↗
• InjurySep 24, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE AORTA. A 5F 145 110 CM IMPULSE GUIDE CATHETER WAS SELECTED FOR USE DURING PROCEDURE. IT WAS OBSERVED THAT THE IMPULSE CATHETER SEPARATED AT THE 145 DEGREE BEND. SUBSEQUENTLY, A SNARE WAS ADVANCED THROUGH THE FEMORAL ACCESS AND THE DETACHED CATHETER'S TIP WAS RETRIEVED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9109982 ↗