Amplatzer™ TorqVue™ 9-TV2-06F120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811806012513), received between Apr 23, 2026 and Apr 23, 2026 — classified as 1 malfunction.

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.

• MalfunctionApr 23, 2026Difficult to Advance; Material Deformation; No Apparent Adverse Event; Material Too Soft/Flexible

  IT WAS REPORTED THAT ON (B)(6) 2026, A 14 MM X 5 MM AMPLATZER VALVULAR PLUG III WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TORQVUE 2 DELIVERY (TV2) SHEATH. DURING PROCEDURE, A TRANSEPTAL PUNCTURE IN SUPERIOR MID SEPTUM ACHIEVED WITH NON-ABBOTT SHEATH AND NON-ABBOTT SYSTEM. THE GUIDEWIRE PLACED INTO LEFT UPPER PULMONARY VEIN (LUPV) AND NON-ABBOTT SHEATH WAS REMOVED AND ANOTHER NON-ABBOTT SHEATH WAS PLACED. A NON-ABBOTT CATHETER 1 AND THEN 2 AND NON-ABBOTT GLIDE WIRE USED TO CROSS DEFECT. THE DEFECT WAS LONG SERPIGINOUS TRACT AND A NON-ABBOTT GUIDE WIRE WAS REPLACED NON- ABBOTT GLIDE. WHEN THE PHYSICIAN ATTEMPTED TO PASS 6F TV2 SHEAT SHEATH THROUGH TRACT. BUT THE PHYSICIAN MENTIONED THE THAT THE TIP OF THE DILATOR WAS TOO SOFT AND WAS EASILY DEFORMED. THE TRANSITIONS WERE NOT TAPERED SUFFICIENTLY TO ALLOW SHEATH TO ADVANCE. THE 6F TV2 SHEATH WAS REMOVED AND 6F NON-ABBOTT SHEATH WAS USED TO PASS THROUGH DEFECT AND 14 MM X 5 MM AMPLATZER VALVULAR PLUG III WAS IMPLANTED. THE CASE TIME WAS EXTENDED DUE TO "MUCKING AROUND" WITH TRYING TO ADVANCE TV2. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24970141 ↗