Amplatzer TorqVueRecalls & reported problems across all models

We found 7 models of Amplatzer TorqVue by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jan 20, 2020 and Jun 11, 2026 — classified as 4 deaths, 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Amplatzer TorqVue recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1644-2025 · Root cause: Process control · Recall details · FDA record ↗

2. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported Amplatzer TorqVue problems

Amplatzer TorqVue models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Amplatzer™ TorqVue™ 9-TVLPC4F90/080

  CATHETER, PERCUTANEOUS
  1 recall3 deaths9 reports
• Amplatzer™ TorqVue™ 9-TVLP4F90/060

  CATHETER, PERCUTANEOUS
  1 recall4 reports
• Amplatzer™ TorqVue™ 9-TVLP4F90/080

  CATHETER, PERCUTANEOUS
  1 recall3 reports
• Amplatzer™ TorqVue™ 9-TVLP5F90/080

  CATHETER, PERCUTANEOUS
  2 reports
• Amplatzer™ TorqVue™ 9-TV2-07F120

  CATHETER, PERCUTANEOUS
  1 death2 reports
• Amplatzer™ TorqVue™ 9-TV2-05F120

  CATHETER, PERCUTANEOUS
  1 report
• Amplatzer™ TorqVue™ 9-TV2-06F120

  CATHETER, PERCUTANEOUS
  1 report

Recent Amplatzer TorqVue adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMay 5, 2026Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 5-4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PATIENT IS 1-YEAR-OLD PATIENT WITH A PDA MEASURING 1 MM AT THE PULMONARY ARTERY (PA) SIDE, 8 MM IN LENGTH, AND AN AMPULLA OF 6.8 MM, DEVICE CLOSURE USING A PICCOLO 5¿4 WAS ATTEMPTED. HOWEVER, THE DELIVERY CATHETER COULD NOT BE ADVANCED ACROSS THE DUCTUS. AN ATTEMPT WAS MADE TO ADVANCE THE PICCOLO INTO THE PA, BUT IT DID NOT EXIT INTO THE PA, AND THE DEVICE WAS RETRIEVED BACK INTO THE DELIVERY CATHETER. DURING RETRIEVAL, RESISTANCE WAS FELT, AND CINE IMAGING REVEALED THAT THE CATHETER TIP HAD FLIPPED UPWARD. THE DELIVERY CATHETER WAS THEREFORE EXCHANGED FOR A NEW ONE. ALTHOUGH PASSAGE TO THE PA WAS STILL NOT ACHIEVED, THE DEVICE WAS SUCCESSFULLY DEPLOYED WITH THE PA SIDE POSITIONED INTRADUCTALLY AND THE AORTIC SIDE DISC SEALING THE DUCTUS, AND THE PROCEDURE WAS COMPLETED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086515 ↗
• 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 ↗
• MalfunctionFeb 11, 2026Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM WAS SELECTED FOR USE. DURING USE, THE SHEATH WAS OBSERVED TO BE BROKEN AND WAS LEAKING SALINE IN A CONTINUOUS DRIP FROM THE HEMOSTASIS VALVE. THE DEVICE WAS EXCHANGED FOR A NEW 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317551 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649728 ↗
• 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 ↗
• 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 ↗
• InjuryMay 24, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A AMPLATZER PICCOLO OCCLUDER 4 MM X 2 MM WAS SELECTED FOR AN IMPLANT USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. DURING STANDARD PLACEMENT PROCESS OF PICCOLO DEVICE, THE PHYSICIAN NOTED MODERATE TRICUSPID REGURGITATION FOLLOWING PICCOLO PLACEMENT AND STANDARD ECHOCARDIOGRAM IMAGING. AFTER THE PROCEDURE A THOROUGH ECHOCARDIOGRAM WAS COMPLETED AND TRICUSPID VALVE REGURGITATION WAS NOTED. THE PHYSICIAN BELIEVED THE OCCLUDER WAS DAMAGED FROM THE NON-ABBOTT CATHETER OR THE 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. HE STATED HE FELT A SLIGHT HANG UP AS HE WAS PASSING THE 4F AMPLATZER TORQVUE LOW PROFILE CATHETER OVER THE NON-ABBOTT WIRE. HE ASSUMED THE DAMAGE OCCURED DURING THIS POINT IN THE PROCEDURE BASED ON THE SLIGHT PRESSURE FELT DURING THIS CATHETER EXCHANGE AND INITIAL INSERTION OF THE4F AMPLATZER TORQVUE LOW PROFILE CATHETER OVER THE NON-ABBOTT WIRE. THE DEVICE WAS EXPLANTED, IT IS UNKNOWN IF A NEW DEVICE WAS IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 19396550 ↗
• MalfunctionApr 25, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT ON (B)(6) 2024, A 4MM BY 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. DURING PROCEDURE, THE PHYSICIAN ATTEMPTED TO RELEASE THE DEVICE, BUT THE DEVICE WOULD NOT LOCK INTO THE CABLE TO ALLOW THE CABLE TO TURN IN UNISON WITH THE DEVICE. THE DEVICE WAS RELEASED FROM THE CABLE BY UTILIZING A HEMOSTAT TO TURN THE CABLE. THE DEVICE WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182300 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_967 - PARADIGM, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 10MMX5MM AMPLATZER VALVULAR PLUG 3 WAS SUCCESSFULLY IMPLANTED IN A PATIENT USING A 5F AMPLATZER TORQVUE 2 DELIVERY SHEATH. ON (B)(6) 2024, IT WAS NOTED THAT THE PATENT WENT TO THE EMERGENCY ROOM DUE TO TESTICULAR PAIN. THE PATIENT WAS FOUND TO HAVE ORCHITIS AND A SCROTAL HEMATOMA. IT BELIEVE THAT THE CAUSE WAS FROM VENOUS ACCESS DURING THE IMPLANT PROCEDURE.

  Patient problems: Hematoma; Pain

  MAUDE report 18743890 ↗
• DeathJan 17, 2024Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED THAT A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM WAS SELECTED FOR A PROCEDURE ON (B)(6) 2023 TO TREAT A PATENT DUCTUS ARTERIOSUS (PDA). IT WAS NOTED THAT THERE WAS DIFFICULTY CANNULATING THE RIGHT VENTRICLE, RIGHT ATRIUM, AND PDA. RESISTANCE WAS OBSERVED WHEN FIRST ATTEMPTING TO CROSS THE DUCT WITH THE CATHETER. THE DECISION WAS MADE TO WITHDRAW THE CATHETER TO THE PULMONARY ARTERY AND ADVANCE THE WIRE TO DUCTUS ARTERIOSUS. RESISTANCE WAS OBSERVED DURING THE SECOND ATTEMPT TO ENTER THE DUCT. AFTER REPOSITIONING THE WIRE THE PATIENT PRESENTED WITH HYPOTENSION AND BRADYCARDIA. IT WAS NOTED THAT MULTIPLE WIRE EXCHANGES WERE DONE. ECHO IMAGING SHOWED A PERICARDIAL EFFUSION AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT CONTINUED TO BECOME HEMODYNAMICALLY UNSTABLE AND CPR WAS PERFORMED. LIFE-SAVING MEASURES WERE PERFORMED. THE PATIENT EXPIRED.

  Patient problems: Bradycardia; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion; Vascular Dissection

  MAUDE report 18527727 ↗

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