Amplatzer™ TorqVue™ 9-TVLP4F90/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806011578), received between Jul 14, 2025 and Oct 29, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 17, 2025Class IIOpen, Classified

   Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

   Z-1643-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM WAS SELECTED FOR USE. DURING USE, AFTER INSERTION INTO THE PATIENT, A HOLE IN THE TUBE OF THE Y-CONNECTOR WAS OBSERVED. LEAK OCCURRED IN A CONTINUOUS DRIP. NO OTHER PARTS OF THE DELIVERY SYSTEM WERE OBSERVED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411268 ↗
• InjuryJul 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON 01 JULY 2025, A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE. DURING PROCEDURE, WHILE CROSSING THE PDA, IT WAS NOTED THAT THE DELIVERY SHEATH WAS KINKED. THE PATIENT HAD A CARDIAC ARREST AND IMMEDIATELY RESUSCITATED. THE PHYSICIAN BELIEVED THE KINKED SHEATH CAUSED THE CARDIAC ARREST. A NEW 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 22592088 ↗
• MalfunctionJul 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM WAS SELECTED FOR USE IN A PDA OCCLUSION PROCEDURE. THE DELIVERY SYSTEM WAS INSPECTED PRIOR TO USE. DURING PROCEDURE, HEMOSTATIC VALVE LEAKAGE OCCURRED AND SALINE WAS OBSERVED TO BE LEAKING. NO PARTS OF THE DELIVERY SYSTEM WERE OBSERVED TO BE DAMAGED. THE DELIVERY SYSTEM WAS EXCHANGED FOR A NEW 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM, WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503577 ↗