AMPLATZER™ 9-TV45X45-10F-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811806012094), received between Dec 27, 2019 and Dec 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Advance” (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 18, 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.

• InjuryDec 27, 2019Difficult to Insert; Difficult to Advance; Positioning Problem; Difficult to Insert; Difficult to Advance; Positioning Problem

  ON (B)(6) 2019, A 20MM AMPLATZER CARDIAC PLUG WAS SELECTED FOR IMPLANT WITH A TORQUE 45X45 10F DELIVERY SHEATH. THE DEVICE ADVANCED IN THE DELIVERY SYSTEM WITHOUT DIFFICULTIES, BUT WAS DEFORMED WHEN DEPLOYED. THE DEVICE WAS RETRACTED. THE PHYSICIAN REPOSITIONED THE DEVICE AT THE INTENDED IMPLANT SITE, BUT HAD DIFFICULTY ADVANCING THE DEVICE AND THE DEVICE FAILED TO DEPLOY. THE DELIVERY SYSTEM AND THE DEVICE WAS REMOVED FROM THE PATIENT. A 13F DELIVERY SYSTEM (LOT # 6203237) AND NEW CARDIAC PLUG (LOT#6187840) WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, ALTHOUGH ADDITIONAL SEDATIVES AND ANTICOAGULANT WERE NEEDED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE ADDITIONAL MEDICATION TREATMENT. NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9526762 ↗