Amplatzer™ TorqVue™ 9-TVLP4F90/060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00811806011561), received between Nov 25, 2024 and Jun 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 4F AMPLATZER TORQVUE LP WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, A HOLE IN THE VALVE WAS NOTED AND A VALVE NOT LEAK-TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466287 ↗
• MalfunctionFeb 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 3MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR A PROCEDURE ON (B)(6) 2025 USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA) FOR A 2-WEEK-OLD PATIENT THAT WEIGHED 1KG. THE DEVICE WAS PREPARED PER IFU. DURING THE PROCEDURE, WHILE ADVANCING THE OCCLUDER THROUGH THE DELIVERY CATHETER IT WAS NOTED THAT THERE WAS A LEAK AT THE PROXIMAL END OF THE DELIVERY CATHETER WHERE THE WHITE TUBING ATTACHES TO THE BLUE CATHETER. THE OCCLUDER WAS SUCCESSFULLY IMPLANTED USING THE SAME DELIVERY CATHETER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21346230 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2024, A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324 DEVICE 1) WAS CHOSEN FOR PROCEDURE DURING A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE ON A 4-WEEK OLD, 1.1KG PATIENT. THE DELIVERY SYSTEM WAS PREPARED. THE DELIVERY SYSTEM WAS INITIALLY USED, BUT IT WAS NOTED TO HAVE A LEAK AT THE PROXIMAL END OF THE CATHETER WHERE THE WHITE TUBING ATTACHES TO THE BLUE CATHETER. THE DELIVERY SYSTEM WAS REMOVED, AND ANOTHER 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324 DEVICE 2) WAS SELECTED FOR USE. DURING DEVICE PREPARATION IT WAS ALSO NOTED TO HAVE A LEAK AT THE SAME SPOT. THE SECOND DELIVERY SYSTEM (LOT 10353324 DEVICE 2) DID NOT MAKE CONTACT WITH THE PATIENT. A THIRD 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10334851) WAS USED TO SUCCESSFULLY DEPLOY THE DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A DELAY IN PROCEDURE, BUT THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783175 ↗
• MalfunctionNov 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2024, A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324) WAS CHOSEN FOR PROCEDURE DURING A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE ON A 4-WEEK OLD, 1.1KG PATIENT. THE DELIVERY SYSTEM WAS PREPARED BY THE SCRUB TECH. THE DELIVERY SYSTEM WAS INITIALLY USED, BUT IT WAS NOTED TO HAVE A LEAK AT THE PROXIMAL END OF THE CATHETER WHERE THE WHITE TUBING ATTACHES TO THE BLUE CATHETER. THE DELIVERY SYSTEM WAS REMOVED, AND ANOTHER 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324) WAS SELECTED FOR USE. DURING DEVICE PREPARATION IT WAS ALSO NOTED TO HAVE A LEAK AT THE SAME SPOT. THE SECOND DELIVERY SYSTEM DID NOT MAKE CONTACT WITH THE PATIENT. A THIRD 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10334851) WAS USED TO SUCCESSFULLY DEPLOY THE DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A DELAY IN PROCEDURE, BUT THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773668 ↗