Amplatzer™ TorqVue™ 9-TVLPC4F90/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00811806012926), received between Apr 2, 2021 and May 5, 2026 — classified as 3 deaths, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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-1644-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• DeathOct 17, 2023Use of Device Problem; Use of Device Problem

  PLEASE REFERENCE MANUFACTURER REPORT NUMBER 2135147-2021-00454 FOR PREVIOUS REPORT REGARDING THIS CASE. IT WAS REPORTED THAT ON (B)(6) 2021, A 3/2 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT USING A 4F AMPLATZER TORQVUE LP CATHETER TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA). THE PATIENT WAS 25 DAYS OLD, 600 G, WITH THE FOLLOWING PDA DIMENSIONS: MINIMAL DUCTAL DIAMETER OF 2.36MM, LENGTH OF 9.6MM. DURING THE PROCEDURE, IT WAS DIFFICULT TO TRAVERSE INTO PULMONARY ARTERY (PA) AND ACROSS THE PDA. ONCE ACROSS THE PDA DEFECT, A CATHETER EXCHANGE WAS PERFORMED FOR THE TORQVUE LP CATHETER, AND THE PICCOLO OCCLUDER WAS DELIVERED AND DEPLOYED INTO THE PDA WITHOUT DIFFICULTY. AT THIS TIME, THE PATIENT BLOOD PRESSURE (BP) STARTED DROPPING A BIT, AND THE HEART RATE INCREASED. THE PHYSICIAN THOUGHT THAT THE CATHETER WAS POSSIBLY DEPRESSED AGAINST THE VALVE AND CAUSING HEMODYNAMIC INSTABILITY. AN ANGIOGRAM WAS PERFORMED SHOWING ABSENCE OF PULMONARY OBSTRUCTION AND GOOD POSITIONING OF THE DEVICE. AN ECHOCARDIOGRAM WAS PERFORMED AND SHOWED ABSENCE OF AORTIC OR PULMONARY OBSTRUCTION, BUT A PERICARDIAL EFFUSION WAS PRESENT. THE DEVICE WAS RELEASED, AND THE DELIVERY SHEATH AND CABLE WERE REMOVED

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion; Tachycardia

  MAUDE report 17950535 ↗
• InjuryJul 24, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT ON (B)(6)2023, A 5MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PATENT DUCTUS ARTERIOSUS (PDA) MINIMAL DIAMETER WAS MEASURED TO BE 3.42MM. THE PDA DIAMETER AT THE AORTIC AMPULLA WAS MEASURED TO BE 3.50MM. THE PDA LENGTH WAS MEASURED AT 8.55MM. IT WAS REPORTED THAT THE DELIVERY CATHETER WAS TOO STIFF AND SIGNIFICANTLY MANIPULATED THE DUCT ANATOMY WHILE ATTEMPTING THE PLACE THE DEVICE. A 4F NON-ABBOTT DELIVERY SHEATH WAS USED TO ACCESS THE PDA VIA THE RIGHT FEMORAL VEIN APPROACH. THE INNER DIAMETER OF THE NON-ABBOTT DELIVERY SHEATH WERE: 4 FR, 1.40 MM I.D. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. 24 HOURS POST PROCEDURE, IT WAS OBSERVED THAT THE PATIENT EXPERIENCED MODERATE TRICUSPID VALVE REGURGITATION VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). ON 7 MARCH 2023, THERE WAS NO NOTICEABLE TRICUSPID VALVE REGURGITATION SEEN ON THE TEE. THE PATIENT WAS REPORTED AS STABLE AND RECOVERED. THERE WAS CONCERN RELATED TO ECHO FINDINGS OF TRICUSPID REGURGITATION THAT RESOLVED "A COUPLE WEEKS LATER" PRIOR TO DISCHARGE BACK TO REFERRING

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 17376266 ↗
• DeathOct 29, 2021Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 29 SEP. 2021, THAT A 3/2 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT USING A 4 F AMPLATZER TORQVUE LP CATHETER. THE PATIENT WAS 25 DAYS OLD, 650 G, WITH PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS OF: MINIMAL DIAMETER 1.77 MM. DURING THE PROCEDURE IT WAS DIFFICULT TO TRAVERSE INTO PULMONARY ARTERY (PA) AND ACROSS THE PDA. ONCE ACROSS THE PDA DEFECT A CATHETER EXCHANGE WAS PERFORMED FOR THE TORQVUE LP CATHETER. AT THIS TIME THE PATIENT BLOOD PRESSURE (BP) STARTED DROPPING A BIT AND THE HEART RATE INCREASED. THE PHYSICIAN THOUGHT THAT THE CATHETER WAS POSSIBLY DEPRESSED AGAINST THE VALVE. THE PDA WAS SIZED AND THE 3/2 AMPLATZER PICCOLO OCCLUDER WAS DEPLOYED INTRADUCTAL AND RELEASED. ONCE THE DEVICE WAS RELEASED A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND REVEALED A PERICARDIAL EFFUSION. THE TEAM SPENT HOURS WORKING ON THE PATIENT BUT THEY UNFORTUNATELY EXPIRED ON 29 SEP. 2021. THE PHYSICIAN ALLEGES THAT THE CAUSE OF DEATH WAS LIKELY DUE TO THE PATIENTS COMORBIDITIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 12719356 ↗
• InjuryApr 2, 2021Biocompatibility; Biocompatibility

  RELATED MANUFACTURING REFERENCE NUMBER: (B)(4). ON (B)(6), 2021, A 4/2 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 22 DAY OLD, 780G PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS(PDA) DIMENSIONS: MINIMAL DIAMETER OF 2.4MM, DIAMETER AT AORTIC AMPULLA OF 3.4MM AND PDA LENGTH OF 6MM. USING AN AMPLATZER TORQVUE LP CATHETER THE DEVICE WAS PLACED INTRADUCTAL AND IT WAS NOTICED VIA ECHO AND FLUOROSCOPY THAT THE DEVICE WAS OVERSIZED. THE PHYSICIAN RECAPTURED THE DEVICE PRIOR TO RELEASE FROM THE DELIVERY CABLE AND REMOVED IT FROM THE PATIENT. A 3/2MM AMPLATZER PICCOLO OCCLUDER WAS THEN SELECTED FOR IMPLANT. THE 3/2MM DEVICE WAS IMPLANTED INTRADUCTAL AND APPEARED TO BE THE CORRECT SIZE FOR CLOSURE, AS IT APPEARED TO SIT WELL. AFTER CAREFUL CONSIDERATION THE PHYSICIAN WAS SATISFIED WITH THE DEVICE PLACEMENT AND RELEASED THE 3/2MM AMPLATZER PICCOLO OCCLUDER IN THE PDA. THE PHYSICIAN THEN PROCEEDED TO PERFORM A FINAL ANGIOGRAM TO CONFIRM PLACEMENT AFTER RELEASE. ANGIOGRAM SHOWED A PERICARDIAL EFFUSION IN THE PATIENT. THE PATIENT THEN WENT INTO COMPLETE HEART BLOCK. THE PATIENT WAS TREATED WITH ATROPINE AND EPINEPHRINE. THE PATIENT WAS THEN CAREFULLY OBSERVED AND NOTED TO GO IN

  Patient problems: Arrhythmia; Heart Block; Pericardial Effusion

  MAUDE report 11607829 ↗