AMPLATZER™ 9-ITV08F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00811806010847), received between Aug 9, 2018 and Sep 25, 2026 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fluid/Blood Leak

  It was reported that on (b)(6) 2026, a 8F Amplatzer TorqVue Delivery System was chosen for a procedure. During procedure, it was noted that the three-way valve is leaking less than 200ml saline. The leak was noted on the connector joint of the delivery system. There was a crack at the joint. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896917 ↗
• MalfunctionSep 25, 2026Fluid/Blood Leak; Fracture

  It was reported that on (b)(6) 2026, a 8F Amplatzer TorqVue Delivery System was chosen for a procedure. During procedure, it was noted that the three-way valve is leaking saline. The location of the leak was at connector joint of the delivery system, leak was less than 200 mL. There is a crack at the joint. The patient remained hemodynamically stable throughout the procedure and there was no delay in the procedure. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896913 ↗
• MalfunctionAug 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50496069 ↗
• MalfunctionAug 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305551 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM WAS CHOSEN FOR A PROCEDURE. DURING DEVICE PREPARATION, SPECIFICALLY DURING THE EXHAUST PROCESS, IT WAS OBSERVED THAT THE DELIVERY SYSTEM HAD SPLIT OPEN AND WAS UNABLE TO EXPEL AIR. IT WAS FURTHER CLARIFIED THAT THE DELIVERY SYSTEM DID NOT COME INTO CONTACT WITH THE PATIENT, AND THE OCCLUDER ALSO DID NOT COME INTO CONTACT WITH THE PATIENT. DUE TO SIGNIFICANT LEAKAGE DISCOVERED DURING THE EXHAUST PROCESS, A NEW 8F AMPLATZER TORQVUE DELIVERY SYSTEM WAS USED AS A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAS NOW RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254098 ↗
• MalfunctionMar 28, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8F AMPLATZER TORQVUE 45/80 WAS UTILIZED DURING A PROCEDURE. WHEN ADVANCING THROUGH THE ANATOMY THERE WAS ADVANCEMENT DIFFICULTY AND THE BLUE TIP BECAME DAMAGED. A REPLACEMENT 9F AMPLATZER TORQVUE WAS ATTEMPTED TO BE USED AS A REPLACEMENT BUT ALSO MET RESISTANCE WHILE ADVANCING WHICH DAMAGED THE BLUE TIP. A NON-ABBOTT REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21723477 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_806 - PFO OCCLUDER PAS US0883- 8866(R813339601) IT WAS REPORTED THAT ON 04 DEC. 2023, A 8F AMPLATZER TORQVUE DS WAS SELECTED TO IMPLANT A DEVICE. SEVERAL HOURS LATER AFTER IMPLANT, PATIENT EXPERIENCED SEVERE GROIN PAIN. COMPUTER TOMOGRAPHY SHOWED "ACUTE RIGHT RETROPERITONEAL HEMATOMA WITH ACTIVE HEMORRHAGE, FAVORED TO ARISE FROM THE PROXIMAL RIGHT INFERIOR EPIGASTRIC ARTERY." PER IR, "SLIGHTLY ABERRANT POSITION OF INFERIOR EPIGASTRIC CROSSES OVER CFV AT ACCESS SITE, PROBABLY TOO SMALL TO SEE BY US DURING ACCESS IN A LARGER PATIENT. THE PATIENT WAS TREATED WITH IR COIL EMBOLIZATION WITH MINX CLOSURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18411026 ↗
• MalfunctionSep 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2023, A 8F AMPLATZER TORQVUE DS WAS SELECTED FOR AN IMPLANT. DURING THE DEVICE PREPARATION, WHEN PUMPING WATER TO REMOVE AIR FROM THE SHEATH, THE SHEATH TUBE LEAKS. DEVICE WAS EXCHANGED TO COMPLETE THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17792310 ↗
• MalfunctionJul 7, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT, USING 8F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEVICE EMBOLIZED AFTER ATTEMPTING TO RECAPTURE INTO THE SHEATH. THE DEVICE WAS RETRIEVED USING GOOSENECK SNARE. A REPLACEMENT 16MM DEVICE WAS SUCCESSFULLY PLACED TO CLOSE THE DEFECT. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17282694 ↗
• InjuryDec 16, 2020Biocompatibility; Biocompatibility

  ON (B)(6) 2020 AN AMPLATZER PFO OCCLUDER WAS CHOSEN FOR CLOSURE PROCEDURE. THE 9-ATV08F45/80 DELIVERY SYSTEM WAS PREPPED AND ADVANCED INTO THE LEFT ATRIUM. A CLOT WAS NOTICED ON THE DELIVERY SHEATH IN THE RIGHT ATRIUM. THE DELIVERY SHEATH WAS REMOVED. CLOT WAS NOTED ON THE SHEATH. THE PROCEDURE WAS THEN ABORTED. THE PATIENT WILL BE TREATED WITH ANTI COAGULATION AND RETURN AT A LATER DATE.

  Patient problems: Thrombus

  MAUDE report 11016731 ↗
• MalfunctionMar 30, 2020Connection Problem; Connection Problem

  REFERENCE MANUFACTURING REPORT NUMBER: 2135147-2020-00139. ON (B)(6) 2020, A 16-14 AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT FOR A SINUS VALSALVA ANEURYSM WITH AN 8F/45 TORQVUE DELIVERY SYSTEM. AFTER DEPLOYING THE DEVICE AND PRIOR TO RELEASE, THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITIONING OF THE DEVICE. THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE, BUT IT PREMATURELY RELEASED FROM THE DELIVERY SYSTEM AND EMBOLIZED TO THE PULMONARY ARTERY. A 10F/45 TORQVUE DELIVERY SYSTEM WAS USED TO RETRIEVE THE DEVICE WITHOUT SUCCESS. THE PATIENT WAS STABLE WHEN REFERRED TO SURGERY TO RETRIEVE THE DEVICE AND CLOSE THE DEFECT. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION.

  Patient problems: Embolism

  MAUDE report 9900948 ↗
• InjuryFeb 20, 2020Biocompatibility; Biocompatibility

  ON (B)(6) 2020, A 14MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, AFTER POSITIONING THE DEVICE, THE PHYSICIAN PERFORMED A LEFT VENTRICULAR ANGIOGRAPHY. A LARGE LEAK WAS OBSERVED FROM THE RIGHT VENTRICLE TO THE PERICARDIUM. THE PHYSICIAN PERFORMED A PERCUTANEOUS PERICARDIOCENTESIS. THE DEVICE WAS RELEASED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND IS TRANSFERRED TO CARDIAC INTENSIVE CARE.

  Patient problems: Pericardial Effusion

  MAUDE report 9733691 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE, A 45/80MM 8F AMPLATZER DELIVERY SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED BUBBLES THAT CREATED A GAS EMBOLISM ON THE CORONARY ARTERIES. THE PATIENT PRESENTED WITH CHEST PAIN. A CORONAROGRAPHY WAS PERFORMED AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Air Embolism

  MAUDE report 8962456 ↗
• InjuryAug 9, 2018Fracture; Fracture

  WHILE INTRODUCING AND ADVANCING THE DELIVERY SHEATH AND DILATOR OF THE 8F AMPLATZER TORQVUE 45 DELIVERY SYSTEM THROUGH A VEIN, A 2-3 CM PORTION OF THE DILATATOR TIP BROKE OFF. THE DELIVERY SHEATH AND DILATOR WERE REMOVED FROM THE PATIENT. THE BROKEN PIECE WAS SNARED OUT FROM THE FEMORAL VEIN IN ITS ENTIRETY. ANOTHER 8F AMPLATZER TORQVUE 45 DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. THE HOSPITAL DISCARDED THE DEVICE AND IT WILL NOT RETURN FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7771154 ↗