Impulse™ H74916391401Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729343639), received between May 29, 2019 and Jun 11, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• InjuryJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PIGTAIL SHEARED OFF AND SNARING OCCURRED. A 5F IMPULSE CATHETER-DIAGNOSTIC WAS SELECTED FOR USE. UPON INSERTING THE CATHETER, THE PIGTAIL PORTION OF THE CATHETER WAS COMPLETELY SHEARED OFF INTO TWO PIECES, A FEW INCHES FROM THE DISTAL TIP. THE FRAGMENT SHOT DOWN THE DESCENDING AORTA AND LODGED NEAR THE RENAL. SNARING WAS USED TO REMOVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511034 ↗
• MalfunctionMar 26, 2021Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE CATHETER. A 5F IMPULSE GUIDE CATHETER WITH A PIGTAIL CURVE WAS SELECTED FOR USE IN A CORONARY ANGIOGRAPHY PROCEDURE. DURING THE PROCEDURE INSIDE THE PATIENT, THE CATHETER KINKED. THIS RESULTED IN AN EXTRA HOLE IN THE CATHETER, WHICH THE GUIDE WIRE WENT THROUGH REPEATEDLY. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE KINK OCCURRED IN THE PIGTAIL CURVE. THE CARRIER TUBE WAS HYDRATED PRIOR TO REMOVING THE DEVICE FROM THE TUBE. A NUMBER OF MINUTES ELAPSED BETWEEN THE HYDRATION OF THE CARRIER TUBE AND THE REMOVAL OF THE DEVICE FROM THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575162 ↗
• MalfunctionJun 21, 2019Fracture; Difficult to Advance; Material Deformation; Material Integrity Problem; Fracture; Difficult to Advance; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED. AN IMPULSE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE OUTSIDE THE PATIENT, IT WAS OBSERVED THAT THE TIP WAS FRACTURED AND THE DEVICE WOULD NOT ADVANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TIP WAS OBSERVED TO BE KINKED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8722987 ↗
• MalfunctionMay 29, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT CATHETER FRACTURE OCURRED. THE TARGET LESION WAS LOCATED IN THE AORTA ARTERY. A 110CM IMPULSE DIAGNOSTIC CATHETER WAS SELECTED FOR USE. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE CATHETER WAS REMOVED AND IT WAS OBSERVED TO BE FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENTS BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650577 ↗