Impulse™ H749163911951Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729213888), received between Oct 14, 2019 and Oct 14, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2019Difficult to Remove; Material Integrity Problem; Positioning Problem; Difficult to Remove; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE A VASOSPAM AND THE CATHETER BECAME LOOPED WITHIN THE ARTERY. THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. AN IMPULSE DIAGNOSTIC CATHETER WAS SELECTED FOR USE TO VIEW THE TARGET LESION. THE CATHETER WAS PREPPED AS USUAL AND WAS ADVANCED TO IMAGE THE RIGHT CORONARY ARTERY. HOWEVER, THE PHYSICIAN LOST TORQUE OF THE CATHETER DURING ENGAGEMENT OF THE TARGET LESION AND IMAGED THE ARM. AN ARTERIAL SPASM OCCURRED WHICH RESULTED IN THE CATHETER LOOPING IN THE RADIAL ARTERY. THE CATHETER BECAME TWISTED AND KINKED DISTAL TO THE SHEATH. SUBSEQUENTLY, A FEMORAL PUNCTURE AND ENTRY WAS MADE TO ATTEMPT TO UNKINK AND UNLOOP THE CATHETER IN THE RADIAL ARTERY. THE CATHETER WAS SNARED TO PROVIDE TENSION AND ALLOW A WIRE TO PASS THROUGH TO UNLOOP AND UNKINK THE CATHETER. THE CATHETER WAS WITHDRAWN AND DISCARDED. THE PROCEDURE WAS COMPLETED WITH NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT IS IN A STABLE AND GOOD CONDITION.

  Patient problems: Vasoconstriction

  MAUDE report 9186257 ↗