AMPLATZER™ 9-ITV07F180/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00811806010793), received between Apr 3, 2019 and Sep 25, 2026 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Retraction Problem; Material Twisted/Bent; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896919 ↗
• MalfunctionAug 28, 2026Difficult to Insert; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506110 ↗
• MalfunctionJun 8, 2026Difficult to Insert; Retraction Problem

  It was reported that on 11 May 2025, an 10-8mm Amplatzer PDA Occluder was chosen for implant using a 7F Amplatzer TorqVue delivery system. It was reported that the device could not be retracted back into the sheath during an attempt to retrieve it for size exchange. No patient complications or adverse events were reported during or after the procedure, and the patient experienced no clinical signs or symptoms. The patient remained hemodynamically stable throughout the procedure, with no clinically significant delay reported, and was stable and discharged post-procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25432165 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  N/A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24433932 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING DEVICE PREPARATION, WHEN THEY WERE FLUSHING THE SYSTEM, LEAKING SALINE WAS OBSERVED IN A CONTINUOUS DRIP ON THE EXTENSION TUBE NEXT TO THE STOPCOCK. THE DEVICE NEVER MADE CONTACT WITH THE PATIENT AND WAS EXCHANGED FOR A NEW 7F AMPLATZER TORQVUE DELIVERY SYSTEM. HOWEVER, LEAKING SALINE ISSUE ALSO OCCURRED AFTER PATIENT CONTACT - LEAK WAS OBSERVED DURING FLUSHING AT THE HEMOSTASIS VALVE. THE DEVICE WAS REPLACED WITH A THIRD NEW UNKNOWN SIZED UNKNOWN MANUFACTURER DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824960 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 7F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING USE AFTER INTRODUCTION INTO PATIENT, IT WAS REPORTED THAT THE "CONNECTIONS WERE LEAKING." SIGNIFICANT SALINE LEAK FROM THE SIDE ARM WAS REPORTED. THE TORQVUE WAS EXCHANGED FOR A NEW 7F AMPLATZER TORQVUE DELIVERY SYSTEM, WHICH WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905857 ↗
• MalfunctionJul 18, 2025Device Damaged by Another Device; Difficult to Advance; Material Deformation; Device Damaged by Another Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 7F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE IN IMPLANT OF A 16-14MM AMPLATZER DUCT OCCLUDER. IT WAS NOTED DURING PROCEDURE THAT THE TIP OF THE DELIVERY SYSTEM APPEARED TOO TIGHT TO ACCOMMODATE THE OCCLUDER. THE DELIVERY SYSTEM APPEARED DEFECTIVE TO THE USER. THE USER HAD INSERTED AND ADVANCED THE OCCLUDER INTO THE 7F AMPLATZER TORQVUE DELIVERY SYSTEM WITH HIGH FRICTION NOTED DURING ADVANCEMENT. THIS RESULTED DAMAGE WITHIN THE DELIVERY SHEATH AND DEFORMATION OF THE TIP OF THE DELIVERY SHEATH. THERE WAS NO DAMAGE TO THE OCCLUDER. THE DECISION WAS MADE TO REPLACE THE 7F AMPLATZER TORQVUE DELIVERY SYSTEM WITH A 8FR AMPLATZER TORQVUE DELIVERY SYSTEM TO COMPLETE THE PROCEDURE SUCCESSFULLY IMPLANTING THE SAME 16-14MM AMPLATZER DUCT OCCLUDER. THE PROCEDURE WAS PROLONGED UNDER GENERAL ANESTHESIA. THE PATIENT HAD NO CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THIS EVENT. THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22544261 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098453 ↗
• MalfunctionMay 7, 2025Retraction Problem; Premature Separation; Retraction Problem; Premature Separation

  IT WAS REPORTED ON (B)(6) 2025 A 12-10MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR A PROCEDURE USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM TO TREAT A PATENT DUCTUS ARTERIOSUS. DURING DEPLOYMENT THE OCCLUDER MOVED TO THE PULMONARY SIDE. AN ATTEMPT WAS MADE TO PARTIALLY RE-CAPTURE THE OCCLUDER AND RE-DEPLOY, HOWEVER THE OCCLUDER COULD NOT BE PARTIALLY RE-CAPTURED TO THE DELIVERY SYSTEM. UPON THE THIRD ATTEMPT TO RE-CAPTURE THE OCCLUDER, THE OCCLUDER PREMATURELY DETACHED FROM THE DELIVERY CABLE AND EMBOLIZED TO THE RIGHT PULMONARY BRANCH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE BUT WAS NOTED TO HAVE LOST A SMALL AMOUNT OF BLOOD. THE PATIENT WAS TRANSFERRED TO SURGERY TO REMOVE THE OCCLUDER. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977856 ↗
• InjuryMay 5, 2025Premature Separation; Premature Separation

  IT WAS REPORTED ON (B)(6) 2025 A 6MM X 4MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA). THE DEVICES WERE PREPARED PER IFU. THE CABLE CONNECTION WAS CHECKED 2-3 TIMES. ANGIOGRAPHY WAS USED TO DETERMINE DEVICE SIZING. DURING THE IMPLANT THE OCCLUDER WAS ADVANCED 5CM FROM THE DELIVERY SHEATH AND PREMATURELY RELEASED FROM THE DELIVERY CABLE. THE LOCATION OF THE DEVICE WAS CONFIRMED TO STILL BE INSIDE THE DELIVERY SYSTEM. A SCALPEL WAS USED TO CUT IN FRONT OF THE LOCATION OF THE DEVICE TO RETRIEVE IT. THE DELIVERY SYSTEM WAS REPLACED WITH A NEW 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THE SAME OCCLUDER WAS USED WITH THE 7F DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961638 ↗
• MalfunctionJun 28, 2024Retraction Problem; Material Twisted/Bent; Retraction Problem; Material Twisted/Bent

  IT WAS REPORTED THAT ON 12 JUNE 2024, A AMPLATZER PATENT DUCTUS ARTERIOSUS (PDA) OCCLUDER (9-PDA- 006 BATCH 8580360) WAS CHOSEN FOR IMPLANT UTILIZING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 9232542). DURING IMPLANTATION, WHEN ATTEMPTING TO RECAPTURE THE DEVICE, THE END OF THE DELIVERY SHEATH BENT AND THE OCCLUDER COULD NOT RECAPTURED. THE DELIVERY SHEATH WAS REPLACED WITH AMPLATZER TORQVUE EXCHANGE SYSTEM 9-EITV08F180/80 (LOT: 8181072) WHICH WAS THEN USED TO RETRACT THE OCCLUDER SUCCESSFULLY. THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED TO BE STABLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632968 ↗
• MalfunctionJun 3, 2024Retraction Problem; Positioning Problem; Retraction Problem; Positioning Problem

  IT WAS REPORTED THAT A 8-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024. DURING THE PROCEDURE THE DEVICE WAS INSERTED INTO THE PATIENT AND ATTEMPTED TO BE DEPLOYED. IT WAS NOTED THAT THE POSITION OF THE DEVICE WAS NOT CORRECT WHEN ATTEMPTING TO CLOSE THE DEVICE. THE DEVICE WAS OBSERVED TO HAVE SLIPPED FROM THE AORTA TO THE MAIN PULMONARY ARTERY. THERE WAS DIFFICULTY RE-CAPTURING THE DEVICE. MULTIPLE ATTEMPTS WERE MADE TO RE-CAPTURE THE DEVICE BUT WERE UNSUCCESSFUL. THE DELIVERY SYSTEM WAS REMOVED AND REPLACED WITH A NEW 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEVICE WAS STILL UNABLE TO BE IMPLANTED. THE OCCLUDER AND DELIVERY SYSTEM WERE BOTH REMOVED FROM THE PATIENT. THE PATIENT WAS REFERRED TO SURGICAL TREATMENT. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455464 ↗
• MalfunctionApr 7, 2023Difficult to Flush; Device Difficult to Setup or Prepare; Difficult to Flush; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT ON (B)(6) 2023, A 7F AMPLATZER TORQVUE DELIVERY SYSTEM WAS CHOSEN FOR PROCEDURE. DURING DEVICE PREPARATION, THE STOPCOCK ON THE HEMOSTASIS VALVE WAS NOT WORKING PROPERLY AND KEPT ROTATING. THE CONNECTION WAS LOOSE AND NOT ABLE TO BE TIGHTENED COMPLETELY. THE STOPCOCK HAD TO BE MANUALLY HELD IN PLACE DURING THE PROCEDURE, AND IT WAS VERY DIFFICULT TO FLUSH THE DEVICE. NO ADVERSE PATIENT EVENTS WERE REPORTED. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701033 ↗
• InjuryMay 26, 2021Retraction Problem; Retraction Problem

  THIS EVENT IS BEING CONSERVATIVELY REPORTED FOR THE PATIENT'S HEMODYNAMIC CHANGES THAT OCCURRED DURING IMPLANTATION OF THE OCCLUDER. ON (B)(6) 2021, A 10/12 PATENT DUCTUS ARTERIOSUS (PDA) DEVICE WAS SELECTED FOR PROCEDURE. THE DEVICE WAS USED WITH THE 7FR DELIVERY SYSTEM. DURING DEVICE PREPARATION, THE SHEATH WAS FINE. WHEN THE DEVICE WAS POSITIONED ON THE PDA FOR CLOSURE, THE HEMODYNAMICS OF THE PATIENT CHANGED AND THE PATIENT BECAME UNSTABLE ON RETRIEVAL WHILE THE USER TRIED TO REPOSITION THE DEVICE, THE DEVICE WOULD NOT PULL INTO THE 7FR SHEATH. THE EFFORT WAS ATTEMPTED 4 TO 5 TIMES WITH LOTS OF RESISTANCE AT THE TIP OF THE SHEATH. THE 7FR DELIVERY SHEATH WAS THEN EXCHANGED FOR A BIGGER SHEATH, A 8FR. THE USER REPORTS THE TIP OF THE SHEATH WAS DEFORMED REPORTING THE TIP OF THE SHEATH (LIGHT BLUE PART) APPEARED INVERTED AND CONCLUDED IT WAS THE REASON FOR THE RESISTANCE. THE DEVICE DID PULL INTO THE 8 FR DELIVERY SHEATH HOWEVER THE 8FR SHEATHS TIP ALSO BECAME DEFORMED. WHILE RETRIEVING THE DEVICE, THE PATIENT REMAINED STABLE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11886728 ↗
• InjuryJun 4, 2019Material Invagination; Retraction Problem; Material Invagination; Retraction Problem

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2019-00145. ON (B)(6) 2019, A 10/8MM AMPLATZER DUCT OCCLUDER (ADO) WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEVICE WAS ATTEMPTED TO BE POSITIONED TWICE, BUT THE DEVICE EMBOLIZED INTO THE PULMONARY ARTERY WHILE ATTACHED TO THE DELIVERY CABLE. THE DEVICE WAS ATTEMPTED TO BE RE-SHEATHED, BUT THE TIP OF THE DELIVERY SYSTEM WAS INVAGINATED PREVENTING A SUCCESSFUL RECAPTURE. THE DEVICE WAS SURGICALLY REMOVED AND THE PATENT DUCTUS ARTERIOSUS WAS LIGATED. THE PATIENT WAS RECOVERY AND SCHEDULED TO BE DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8669059 ↗
• InjuryApr 3, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2019, A AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. THE USE BY DATE (UBD) WAS NOTED TO BE (B)(6) 2018, BUT THE PHYSICIAN ELECTED TO USE THE DEVICE. THE PATIENT EXPERIENCED NO BLEEDING OR INFECTION AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478597 ↗