AMPLATZER™ 9-ITV07F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811806010816), received between Nov 13, 2018 and Apr 2, 2021 — classified as 1 injury, 1 malfunction.

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

• MalfunctionApr 2, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2021-00127. ON (B)(6) 2021, A 10-8 MM AMPLATZER DUCT OCCLUDER WAS SELECTED TO CLOSE OFF A DUCT CREATED BY A TRANSCAVAL TAVR PROCEDURE. A TORQVUE DEVICE LOADER WAS USED TOGETHER WITH AN AGILIS CATHETER. DURING THE LOADING OF THE DEVICE THERE WAS SOME RESISTANCE NOTED. THE PHYSICIAN POSITIONED THE DEVICE AND DEPLOYED THE DISTAL END (NOT FULLY), WHILE TRYING TO FIND THE OPTIMAL POSITION IT WAS NOTED THAT THE DEVICE HAD BECOME DETACHED FROM THE TORQVUE DELIVERY CABLE. AN ENSNARE WAS THEN USED TO SNARED AND REMOVE THE DEVICE THROUGH THE AGILIS CATHETER. UPON INSPECTION IT WAS NOTED THAT THE THREADS OF THE ENDSCREW OF THE TORQVUE DELIVERY CABLE BROKE OFF IN THE ENDSCREW ON THE OCCLUDER. A NEW 6 MM AMPLATZER DUCT OCCLUDER AND TORQVUE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609639 ↗
• InjuryNov 13, 2018Retraction Problem; Retraction Problem

  ON (B)(6) 2018, A 16MM AMPLATZER SEPTAL OCCLUDER (ASO) AND 7F AMPLATZER TORQVUE 45 DELIVERY SYSTEM (DTV45) WERE SELECTED. DURING DEPLOYMENT, THE DEVICE FORMED INTO A COBRA SHAPE AND WAS DIFFICULT TO RESHEATH. A 9F AMPLATZER TORQVUE EXCHANGE SYSTEM (ETV) WAS USED TO REMOVE THE 16MM ASO. A SECOND 16MM ASO WAS DEPLOYED USING THE ORIGINAL DTV45 DELIVERY CABLE THROUGH THE 9F ETV TO SUCCESSFULLY COMPLETE THE PROCEDURE. PER REPORT THE PROCEDURE WAS EXTENDED BY 36 MINUTES. THE PATIENT DID NOT HAVE ANY ADVERSE CONSEQUENCES AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8067145 ↗