Amplatzer TorqVue 45° x 45°Recalls & reported problems across all models

We found 2 models of Amplatzer TorqVue 45° x 45° by Aga Medical Corporation in the FDA's device registry (GUDID). Together they are named in 113 adverse event reports in the FDA's MAUDE database, received between Oct 8, 2018 and Sep 18, 2026 — classified as 9 deaths, 46 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (43 reports).

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

Most reported Amplatzer TorqVue 45° x 45° problems

Amplatzer TorqVue 45° x 45° models

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

• Amplatzer™ TorqVue™ 45° x 45° Delivery Sheath

  CATHETER, PERCUTANEOUS
  7 deaths73 reports
• Amplatzer™ TorqVue™ 45° x 45° Delivery Sheath

  CATHETER, PERCUTANEOUS
  2 deaths40 reports

Recent Amplatzer TorqVue 45° x 45° adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Advance; Material Split, Cut or Torn

  It was reported that on (b)(6) 2026, a 14F Amplatzer Amulet Delivery Sheath was chosen for a procedure. The patient was reported to have tortuous anatomy, which made advancement of the delivery sheath and dilator difficult. Prior to the procedure, the delivery sheath was inspected for damage, kinks, or obstructions. The device was properly flushed and prepared according to the IFU before attempting delivery. During removal of the sheath and dilator, a tear was observed in the dilator. As a result, the delivery system was replaced with a new 14F Amplatzer Amulet Delivery Sheath (Lot: 11347613). Upon use of a second delivery system, a similar issue was encountered. The physician subsequently removed the system to further dilate the vascular access site. During removal, it was noted that the guidewire had split the second TorqVue delivery system. Later, a third delivery system which is a 14F Amplatzer Amulet Delivery Sheath (Lot: 11347613) was successfully used to complete the procedure. The physician reported that the issue was not with the delivery system, but rather the patient's difficult anatomy. The patient remained hemodynamically stable throughout the procedure. There was no c

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819077 ↗
• MalfunctionSep 18, 2026Material Split, Cut or Torn

  It was reported that on (b)(6) 2026, a 14F Amplatzer Amulet Delivery Sheath was chosen for a procedure. The patient was reported to have tortuous anatomy, which made advancement of the delivery sheath and dilator difficult. Prior to the procedure, the delivery sheath was inspected for damage, kinks, or obstructions. The device was properly flushed and prepared according to the IFU before attempting delivery. During removal of the sheath and dilator, a tear was observed in the dilator. As a result, the delivery system was replaced with a new 14F Amplatzer Amulet Delivery Sheath (Lot: 11347613). Upon use of a second delivery system, a similar issue was encountered. The physician subsequently removed the system to further dilate the vascular access site. During removal, it was noted that the guidewire had split the second TorqVue delivery system. Later, a third delivery system which is a 14F Amplatzer Amulet Delivery Sheath (Lot: 11347613) was successfully used to complete the procedure. The physician reported that the issue was not with the delivery system, but rather the patient's difficult anatomy. The patient remained hemodynamically stable throughout the procedure. There was no c

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819047 ↗
• MalfunctionSep 8, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680143 ↗
• MalfunctionMar 20, 2026Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, A 14 F AMPLATZER TORQVUE DELIVERY SHEATH WAS CHOSEN FOR A PROCEDURE. THE DELIVERY SHEATH WAS INSPECTED FOR DAMAGE, KINKS, OR OBSTRUCTIONS PRIOR TO USE AND FOUND ACCEPTABLE, AND IT WAS PROPERLY FLUSHED AND PREPARED PER THE IFU BEFORE DELIVERY. THE PATIENT¿S ANATOMY WAS REPORTED TO BE TORTUOUS. DURING ADVANCEMENT OF THE DELIVERY SYSTEM OVER THE WIRE INTO THE FEMORAL ACCESS SITE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SHEATH AND ENCOUNTERED RESISTANCE IMMEDIATELY PAST THE SKIN. THE DELIVERY SYSTEM HAD NOT CONTACTED THE GUIDEWIRE PRIOR TO THE SPLIT TIP BEING NOTICED (PLACING OVER THE WIRE, NO DAMAGE VISUALIZED). AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN REMOVED THE SHEATH OVER THE WIRE AND OBSERVED THAT THE DILATOR WAS DAMAGED, WITH A SMALL TEAR AT ITS DISTAL END. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW 14F AMPLATZER TORQVUE DELIVERY SHEATH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651966 ↗
• MalfunctionFeb 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER AMULET WAS CHOSEN FOR A PROCEDURE USING A 14 F AMPLATZER TORQVUE DELIVERY SYSTEM. IT WAS OBSERVED THAT THE DELIVERY SYSTEM'S SHEATH SPLIT WHILE ADVANCING UP THE PATIENT'S GROIN. THERE WAS NO DAMAGE OBSERVED PRIOR TO OPENING AND THE FLUSHING WAS DONE ACCORDING TO IFU. THE DELIVERY SYSTEM WAS REPLACED BY A 14F AMULET STEERABLE DELIVERY SHEATH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240462 ↗
• DeathJan 20, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED ON 22 DECEMBER 2025, TWO 14F DELIVERY SYSTEMS WERE CHOSEN TO BE USED IN THE PROCEDURE DURING THE CASE. ONE TORQVUE SHEATH WAS INITIALLY USED, AND A SECOND TORQVUE SHEATH WAS SUBSEQUENTLY INTRODUCED AFTER PLACEMENT OF AN OUTER SHEATH DUE TO THE TORTUOUS VEIN. THE DELIVERY SHEATH AND PIGTAIL CATHETER WERE POSITIONED AT THE OSTIUM OF THE APPENDAGE. THE FIRST RAU/CRANIAL FLUOROSCOPIC IMAGE WAS OBTAINED. AS THE TEAM PREPARED TO ACQUIRE THE RAU/CAUDAL IMAGE, THE PATIENT¿S BLOOD PRESSURE BECAME SOFT. THE PROCEDURE WAS STOPPED IMMEDIATELY, AND THE DELIVERY SHEATH AND PIGTAIL CATHETER WERE REMOVED FROM THE LEFT ATRIUM. CHEST COMPRESSIONS WERE INITIATED. A PLEURAL EFFUSION WAS IDENTIFIED INTRAPROCEDURALLY ONCE CHEST COMPRESSIONS BEGAN, AND THIS EFFUSION WAS ASSESSED AS NOT RELATED TO THE PROCEDURE OR THE ABBOTT DEVICES. THE COMPRESSIONS WERE REPORTED TO HAVE WORSENED THE EFFUSION, AND THE PATIENT¿S PRESSURES DID NOT RECOVER. THE PLEURAL EFFUSION COULD NOT BE RESOLVED, AS THE PATIENT NEVER BECAME STABLE ENOUGH FOR INTERVENTION. IMAGING CONFIRMED THE EFFUSION DURING RESUSCITATIVE EFFORTS. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2025, WITH THE CAUSE OF DEATH DOCUMENTED AS PLEUR

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions; Pleural Effusion

  MAUDE report 24122413 ↗
• DeathJan 20, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 22 DECEMBER 2025, TWO 14F DELIVERY SYSTEMS WERE CHOSEN TO BE USED IN THE PROCEDURE DURING THE CASE. ONE TORQVUE SHEATH WAS INITIALLY USED, AND A SECOND TORQVUE SHEATH WAS SUBSEQUENTLY INTRODUCED AFTER PLACEMENT OF AN OUTER SHEATH DUE TO THE TORTUOUS VEIN. THE DELIVERY SHEATH AND PIGTAIL CATHETER WERE POSITIONED AT THE OSTIUM OF THE APPENDAGE. THE FIRST RAU/CRANIAL FLUOROSCOPIC IMAGE WAS OBTAINED. AS THE TEAM PREPARED TO ACQUIRE THE RAU/CAUDAL IMAGE, THE PATIENT¿S BLOOD PRESSURE BECAME SOFT. THE PROCEDURE WAS STOPPED IMMEDIATELY, AND THE DELIVERY SHEATH AND PIGTAIL CATHETER WERE REMOVED FROM THE LEFT ATRIUM. CHEST COMPRESSIONS WERE INITIATED. A PLEURAL EFFUSION WAS IDENTIFIED INTRAPROCEDURALLY ONCE CHEST COMPRESSIONS BEGAN, AND THIS EFFUSION WAS ASSESSED AS NOT RELATED TO THE PROCEDURE OR THE ABBOTT DEVICES. THE COMPRESSIONS WERE REPORTED TO HAVE WORSENED THE EFFUSION, AND THE PATIENT¿S PRESSURES DID NOT RECOVER. THE PLEURAL EFFUSION COULD NOT BE RESOLVED, AS THE PATIENT NEVER BECAME STABLE ENOUGH FOR INTERVENTION. IMAGING CONFIRMED THE EFFUSION DURING RESUSCITATIVE EFFORTS. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2025, WITH THE CAUSE OF DEATH DOCUMENTED AS PLEUR

  Patient problems: Low Blood Pressure/ Hypotension; Pleural Effusion

  MAUDE report 24122238 ↗
• MalfunctionJan 6, 2026Material Separation; Improper or Incorrect Procedure or Method; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12F AMPLATZER TORQVUE SHEATH WAS CHOSEN FOR A PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE DEVICE SHAVINGS WERE VISIBLE ON THE ECHOCARDIOGRAPHY, AFTER THE DEVICE WAS CHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981024 ↗
• MalfunctionJan 5, 2026Retraction Problem; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  IT WAS REPORTED THAT (B)(6) 2025, A 14F AMPLATZER TORQVUE SHEATH WAS CHOSEN FOR A PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO RECAPTURE A 31MM AMULET DEVICE THROUGH THE 14F SHEATH FOR DEVICE REMOVAL. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN UTILIZED BALLOONING OF THE CATHETER TIP TO FACILITATE RECAPTURE OF THE DEVICE INTO THE DELIVERY SHEATH. THE DELIVERY CATHETER HAD PREVIOUSLY BEEN USED FOR TWO DEVICE RESIZING ATTEMPTS. THE PHYSICIAN WAS INFORMED THAT, PER THE INSTRUCTIONS FOR USE (IFU), THE DELIVERY SYSTEM SHOULD BE REPLACED WITH EACH FULL RECAPTURE AND EXCHANGE OF THE DEVICE. DESPITE THIS, THE SAME CATHETER WAS USED. DURING DEVICE PREPARATION, WAS THERE NO ISSUE RETRACTING DEVICE INTO THE DELIVERY SYSTEM. POST-PROCEDURE ASSESSMENT REVEALED THE CATHETER WAS KINKED IN TWO LOCATIONS. THE PHYSICIAN NOTED THAT THE PATIENT¿S TORTUOUS ANATOMY MAY HAVE CONTRIBUTED TO THE ISSUE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967817 ↗
• MalfunctionDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE SHEATH DILATOR SPLIT WAS NOTICED AFTER BEING USED AND HAD TO USE AGAIN DUE TO REDOING TRANSEPTAL. A NEW 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851433 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23729851 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) - VERITAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER AMULET 2 WAS CHOSEN FOR IMPLANT. POST-PROCEDURE ON (B)(6) 2025, A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) NOTED A LEFT TO RIGHT RESIDUAL SHUNT THROUGH THE TRANSSEPTAL PUNCTURE. NO TREATMENT OR INTERVENTION WAS REQUIRED.

  Patient problems: Perforation

  MAUDE report 23605860 ↗
• MalfunctionNov 7, 2025Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING PROCEDURE, THE DOC'S SHEATH CAME OUT OF THE APPENDAGE AND ACCIDENTALLY WENT ACROSS MITRAL VALVE WHILE IN BALL AND HIT THE MITRAL ANNULUS MULTIPLE TIMES. THE FIRST DEPLOYMENT WAS SO DEEP THAT IT WASN'T SEEN WELL ON IMAGING. THERE WERE MULTIPLE REDEPLOYMENTS AND A NEW 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN. DURING THE FIRST DEPLOYMENT OF THE SECOND DEVICE, WHEN THE DISC WAS DEPLOYED THE LOBE JUMPED UP MORE PROXIMALLY. THE DOC REDEPLOYED TWICE AND THEY LEFT A GOOD IMPLANT. AFTER RELEASE, A PERICARDIAL EFFUSION WAS NOTED THAT GREW BIGGER. A PERICARDIOCENTESIS WAS PERFORMED AND REMOVED 458CCS OF BLOOD. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497994 ↗
• MalfunctionOct 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON (B)(6) 2025 A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING THE PROCEDURE UNIDENTIFIED MATERIAL WAS OBSERVED ATTACHED TO THE END OF THE DELIVERY SHEATH WHILE ATTEMPTING TO DEPLOY THE OCCLUDER. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT 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 23224995 ↗
• DeathSep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS USED FOR A PROCEDURE. THE PATIENT HAS A PAST MEDICAL HISTORY OF CABG, BIOPROSTHETIC AVR, CEREBRAL ANEURYSM, AND ATRIAL FIBRILLATION. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE HOSPITAL WITH STROKE SYMPTOMS. COMPUTED TOMOGRAPHY (CT) FOR LARGE VESSEL OCCLUSION WAS NEGATIVE. WITHIN 8 HOURS OF ADMISSION, THE PATIENT BECAME BRADYCARDIC WITH WORSENING NIH SCORE. REPEAT CT SHOWED NEW INTRACEREBRAL HEMORRHAGE. TRANEXAMIC ACID BOLUS WAS GIVEN AND ON (B)(6) 2024, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR ADMISSION. THE PATIENT RECEIVED MEDICATIONS AND MAINTAINED ABILITY TO SPEAK AND FOLLOW COMMANDS. ON (B)(6) 2024, THE PATIENT BEGAN TO DEVELOP RESPIRATORY FAILURE. THEREFORE, ON (B)(6) 2024, THE PATIENT WAS INTUBATED. "DESPITE ATTEMPTS MADE TO OPTIMIZE CLINICAL CONDITION," THE PATIENT CONTINUE TO FAIL. THE PATIENT DENIED TRACH AND ON (B)(6) 2024, TERMINAL EXTUBATING WAS PERFORMED; THE PATIENT PASSED SHORTLY AFTER EXTUBATING.

  Patient problems: Bradycardia; Intracranial Hemorrhage; Respiratory Insufficiency

  MAUDE report 23089961 ↗