AMPLATZER™ 9-ITV07F45/60Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811806010809), received between Jan 11, 2022 and Jan 11, 2022 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 7F AMPLATZER TORQVUE DELIVERY SYSTEM WAS CHOSEN FOR PROCEDURE IN A VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE CASE. WHILE DOING A RETROGRADE ARTERIOVENOUS (AV) LOOP, AFTER ADVANCING THE TORQVUE SHEATH THROUGH THE RIGHT VENTRICLE, THE PATIENT WENT INTO ASYSTOLE AND IT WAS NOTICED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) PERMANENT PACING LEAD HAD BECOME DISLODGED. THE PATIENT REQUIRED EMERGENT PERCUTANEOUS PACING AND CPR, AND THE PATIENT WAS IN ASYSTOLE FOR A TOTAL OF LESS THAN 60 SECONDS. THE PROCEDURE HAD TO BE ABORTED WITHOUT SUCCESSFUL CLOSURE OF THE VSD. THE PATIENT RECEIVED THE NEW RV LEAD 30 MINUTES AFTER THE VSD CLOSURE PROCEDURE WAS ABORTED. THE PHYSICIAN NOTED THAT THE TRAJECTORY OF DELIVERING THE SYSTEM THROUGH THE VSD WAS CHALLENGING. DUE TO THE DIFFICULT ANGLE, THE DELIVERY SYSTEM MAY HAVE DISLODGED THE LEAD, BUT THIS WAS UNABLE TO CONFIRMED. THERE WAS NO VISUALIZATION OF THE LEAD BEING DISLODGED, AND IT WAS ONLY NOTICED AFTER THE PATIENT WAS IN ASYSTOLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Asystole

  MAUDE report 13226601 ↗