Impulse™ H74916599400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729304975), received between Dec 17, 2019 and Jul 1, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS THROMBUS PRESENT IN THE PATIENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN SUCCESSFULLY PERFORMED THE TRANSSEPTAL PUNCTURE AND THEN INSERTED THE WAS INTO THE PATIENT. THE IMPULSE PIGTAIL CATHETER WAS INSERTED TO HELP POSITION THE WAS IN THE LAA OF THE PATIENT. THE IMPULSE PIGTAIL CATHETER WAS THEN REMOVED FROM THE PATIENT, AND IT WAS NOTED THAT THERE WERE CLOTS ALL OVER THE DEVICE. THE PHYSICIAN ASPIRATED THE WAS, BUT NO THROMBUS REMAINED IN THE PATIENT. THE PHYSICIAN CONTINUED THE PROCEDURE USING THE SAME WAS. THE WDS WAS INSERTED, AND THE CLOSURE DEVICE WAS DEPLOYED IN THE PATIENT. AFTER ALL RELEASE CRITERIA WAS MET THE CLOSURE DEVICE WAS RELEASED FROM THE CORE WIRE OF THE WDS AND SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY OTHER COMPLICATIONS AND IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19643570 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A DISSECTION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED IN THE LAA AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS INSERTED INTO THE WAS. THE CLOSURE DEVICE WAS DEPLOYED, BUT WAS TOO PROXIMAL, SO IT WAS FULLY RECAPTURED. IT WAS DEPLOYED AGAIN, BUT DID NOT MEET THE RELEASE CRITERIA, SO IT WAS FULLY RECAPTURED AGAIN. ON THE THIRD DEPLOYMENT, THE CLOSURE DEVICE DID NOT EXPAND. IT WAS FULLY RECAPTURED AND REMOVED FROM THE PATIENT. ANOTHER 24MM WATCHMAN FLX CLOSURE DEVICE WAS USED IN A DIFFERENT LOBE. IT WAS DEPLOYED, BUT WAS TOO PROXIMAL, SO A FULL RECAPTURE WAS PERFORMED AND THE WDS WAS REMOVED FROM THE PATIENT. AN IMPULSE PIGTAIL CATHETER WAS INSERTED AGAIN INTO THE WAS TO ACHIEVE THE VERY FIRST POSITION. AFTER CONTRAST WAS GIVEN, AN INTIMAL DISSECTION WAS SEEN IN THE LAA. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS ABORTED. THE PATIENT EXPERIENCED LOW BLOOD PRESSURE AND WENT TO THE EMERGENCY ROOM WHERE ATERENOL WAS ADMINISTERED. THE PATIENT IS CURRENTLY FINE AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 9484306 ↗